Job Description Summary

SUMMARY:
The Quality Assurance (QA) Specialist works in the Quality Systems (QMS_ area and oversees quality system requests and systems. The QA Specialist is the point of contact for the Madison BD Interventional Sterilization (BDIS) Quality System elements such as the purposes of quality system processes, regulatory compliance, and other business needs.

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following (Other duties may be assigned):
•    Coordinate the fulfillment of Madison BDIS QMS requests.  These requests include, but are not limited to:
o    Regulatory and Quality System information
o    Quality system documentation
•    Serve as a subject matter expert on quality system processes.  Research, analyze and communicate with requestors as needed to ensure requests are fulfilled accurately and in a timely manner.

•    Serve as the site’s NC leader and process owner. Participate in the Material Review Board (MRB) process and develop and manage site’s nonconformances and metrics.
•    Serve as the site’s CAPA leader and process owner. Participates in the BD UCC CAPA Review Board process and develops and manages site’s CAPA Review Board (as applicable)
•    Serve as the site’s SME for the Electronic Document Management System, Electronic Nonconformance System, and Electronic DHR system.
•    Collaborate with process owners with other manufacturing sites or Business Units to secure customer requested information.
•    Determine and pursue courses of action necessary to obtain desired results. 
•    Plans and participates in disciplines strategically relevant to the business and/or functions

 •    Liaison with QA Manager, Operations Management, and Lot Release teams to identify and investigate QA related sterilization issues.
•    Track, maintain and manage QMS Documentation Requests.
•    Manage and maintain records in compliance with record retention requirements.
•    Assist other members of Quality Systems team via cross training as needed.
•    Other departmental/process improvement projects as required.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

•    Proficient in the use of a personal computer with intermediate level of keyboarding skills with proficiency in Microsoft Word, Excel, PowerPoint and Access.
•    Proficient in the use of Electronic Data Management systems.
•    Detailed oriented and strong organizational skills.
•    Strong communication, customer service, writing, analytical and problem-solving skills. 
•    Ability to independently research and organize technical (QA/RA) product information for requests.
•    Ability to be flexible in a fast-paced environment.
•    Ability to multitask and prioritize effectively. 
•    Ability to apply common sense understanding to carry out instructions furnished in oral, written, or diagram form.  
•    Ability to solve practical job-related problems while working independently with minimal supervision.

EDUCATION and/or EXPERIENCE:

•    Bachelor’s degree preferred.
•    One (1) to three (3) years of related experience working with controlled documents or data management and/or training within a regulated industry required.
•    Familiarity with technical wording and documentation.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

Primary Work Location

USA GA - Madison

Additional Locations

USA GA - Covington BMD

Work Shift

Job Summary

Avantor is looking for a steadfast and analytical Quality Assurance Manager to champion our Quality Control & Assurance team, and deliver continuous compliance for Avantor’s Buford, Georgia site.

This role will be a full-time position based out of our Buford, Georgia facility with 5% domestic and international travel (as needed). You will have the opportunity to partner with stakeholders and customers, influence and guide internal associates, and cross-collaborate with leaders at Avantor’s domestic and international facilities. If you have experience in Quality Control and Quality Assurance and are passionate about people leading – let’s talk!

The team

Avantor’s Quality Control & Assurance team is part of our Global Services Quality business unit. This team supports the quality systems and compliant readiness for the Buford, Georgia site by upholding Quality Assurance (QA) and Quality Control (QC) programs in addition to all applicable certified regulations and standards.

What we’re looking for

• Education: Associate’s Degree or equivalent education is required

• Experience: 6 – 8+ years of related Quality experience required

  • 1 – 3+ years of people management experience required

• Collaboration Tool: Microsoft Teams experience preferred

• Preferred Qualifications:

  • Bachelor’s Degree in a related field

  • Bilingual in Spanish

  • Experience working in a regulated industry (medical devices, API, pharmaceuticals, etc.)

  • Functional knowledge of Microsoft Outlook, Word, and Excel (or equivalent)

  • Previous exposure and experience with automated inventory control systems

How you will thrive and create an impact

• Lead all aspects of and ensure Quality Assurance program, Quality Assurance leadership and associates.

• Direct CAPA program and support Lead Auditor to ensure CAPA and audit programs (internal and external) are sound.

• Close or raise complaints / CAPA inputs.

• Attend to and guide inspections as required.

• Oversee systems that effect quality of product.

• Be responsible for product recalls.

• Maintain the integration of FDA regulations and ISO standards into the Quality Management System (QMS).

• Direct implementation, conduct audits, and oversee application of business Quality Management System (ISO/QSR).

• Lead customer audits, including audit preparation, documentation, follow-up, and closure.

• Support supplier evaluation program, including supplier audit program. Review program and advise Purchasing where issues exist.

• Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.

• Solid understanding of and support compliance with ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR).

• Evaluate and advise management on current, new or proposed regulations and standards changes. Provide enterprise-wide strategic insight to senior management.

• Support and advise vital continuous improvement projects as a result of periodic trend reporting including but not limited to; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality event.

• Use Six Sigma and Lean Manufacturing methodology to drive quality system improvements.

• Build, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned.

• Coordinate and support ETQ Reliance Software based on Global Compliance Direction.

• Deploy effective root cause analysis enterprise-wide.

• Prepare, conduct, and offer necessary recommendation training on quality assurance concepts and tools, as requested.

• Consult with Sales on viability and capabilities of new products including; understand product workflow from start to finish, review design process and ensure finished good(s) meets written expectations/specifications as it relates to customer specifications.

• Lead Complaint Investigation efforts, including managing weekly meetings and reviewing prior to closure.

• Conduct periodic review of complaint process, audit program, and related quality programs.

• Support validation program.

• Performs other duties as assigned.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Works in an administrative area thermostatically controlled to room temperature with adequate lighting and ventilation.

May work a portion of the day on the production floor thermostatically controlled to room temperature with adequate lighting and ventilation and with occasional elevated noise levels. May work a portion of the day in a general warehouse environment with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures.

Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

A frequent volume of work and deadlines impose strain on routine basis.

Minimal physical effort is required.

#LI-Onsite

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people’s lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom’s voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

EEO Statement:

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Job Description Summary

The Manager, Quality Assurance reports directly to the Associate Director, Quality and is responsible for managing the quality activities and personnel for multiple departments in the plant including injection molding. The manager will coordinate efforts for corrective and preventive action, non-conforming material investigations, and internal and external audits. They will assure manufacturing and support areas are compliant to regulations, standards, and internal procedures. The manager will support continuous improvement activities for the manufacturing and quality systems. They will provide regular updates to management of trends from these areas and oversee training and development activities for quality personnel in area.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

RESPONSIBILITIES

• Lead quality activities and compliance programs for multiple departments in the plant including oversight for CAPAs, QNs, temporary deviations, and internal audits.

• Participate on the plant quality leadership team to ensure compliance for the manufacturing plant to local procedures, regulations, and standards for medical devices and pharmaceutical products.

• Key member of the quality executive steering committee to drive quality system improvement projects and support individual department and plant continuous improvement goals.

• Participate as a team member on blitzes, six sigma projects, etc.

• Responsible for analyzing quality data trends and initiating projects to address deficiencies.

• Empower quality associates to seek out opportunities to improve quality and compliance.

• Assist quality engineers, production managers, engineers, and supervisors on identification of root cause of quality problems.

• Coordinates presentations for management review and platform meetings for areas of responsibility.

• People leader for quality engineers and other quality personnel (calibration, laboratories, technicians, etc.) as assigned.

• Coach and mentor quality engineers and other quality personnel in the plant. Assist associate director of quality to support external audits (FDA, ISO, corporate audits, customer audits, etc.).

• Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.

• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

• Other duties as assigned.

DELIVERABLES

• Develop a high performing quality assurance team.

• Deliver on annual quality and operations goals.

• Ensure compliance to regulations and procedures in department.

QUALIFICATIONS AND REQUIREMENTS

Education:

• Bachelor’s degree in a science, engineering, or other relevant discipline required.

Experience:

• Minimum of 5 years quality assurance or relevant technical experience required.

• Minimum of 1 years direct supervision experience required.

• Leadership experience, project management, and advanced communication skills required.

• Experience with 21 CFR 820-21/211 cGMP, ISO 13485-9001 preferred.

• Experience working in injection molding preferred.

• Medical device or pharmaceutical experience preferred.

• ASQ certification (CQE or CQA) preferred.

• High-level analytical problem solving, technical writing, and root cause analysis skills preferred.

• Continuous improvement experience or six sigma green belt certification or training is preferred.

• Process validation and design of experiment (DOE) experience preferred.

• Experience with Minitab, SAP, and Trackwise preferred.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

PDN

Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
Responsible for assisting in the implementation and maintenance of an effective Quality System for the site.

What You'll Do

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Independently contribute to Quality System processes which may include training, corrective action and preventive action 
• (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Determine quality attributes and requirements. may provide technical assistance.
• Independently utilize quality management techniques to perform investigations and facilitate solutions.
• Responsible for independently completing documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under general supervision of more experienced staff who review results for overall accuracy, completeness and 
• sound judgment
• identifies and quantifies technical risks and their consequences relative to the success of part of a project.
• Recommends appropriate action; decisions or recommendations would typically achieve department / project objectives.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management; may mentor other.

Minimum Qualifications

• Bachelor's Degree (± 16 years)
• Minimum 2 years related experience.
• Demonstrated technical competency and working technical knowledge and application of concepts, practices and procedures.
• Strong organizational and project management skills
• Demonstrated initiative and problem-solving skills and critical thinking skills.

Preferred Qualifications

• Master's degree preferred.
• CAPA or NC author or owner
• Ability or aptitude to work on problems of moderate scope.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action.
• Ability and aptitude to use various types of databases and other computer software.
• Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.

     

The base pay for this position is

$65,200.00 – $130,400.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CMI ARDx Cardiometabolic and Informatics

        

LOCATION:

United States > Carlsbad : 2251 Faraday Ave

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

CAPA Quality Specialist

 

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

 

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

 

The Opportunity

This position works out of our Irving, TX location in the Core Diagnostic Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

 

As the CAPA Quality Specialist, you’ll be responsible for assisting in the implementation and maintenance of an effective Quality System for the site.

 

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.

• Independently contribute to Quality System processes which may include training, corrective action, and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.

• Determine quality attributes and requirements. may provide technical assistance.

• Independently utilize quality management techniques to perform investigations and facilitate solutions.

• Responsible for independently completing documentation in a timely manner and in accordance with business standards.

• Supports required activities for monthly metrics and drive decisions in a timely manner.

• Ensure work complies with regulatory and compliance standards.

• Ability to communicate constructively and utilize technical writing skills for quality records.

• Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.

• Manage and coordinate CAPA projects and identify continuous improvement opportunities.

• Ability to investigate and utilize DMAIC problem solving tools.

• Understand and comply with applicable EHS policies, procedures, and guidelines.

• Works under general supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment; identifies and quantifies technical risks and their consequences relative to the success of part of a project; recommends appropriate action; decisions or recommendations would typically achieve department / project objectives; drives functional performance to ensure that cross-functional standards and expectations are met; may assist in the training of personnel as directed by management; may mentor others.

• Assist with other support duties as assigned.

• Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.

• Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.

• Collaborates with members of the Quality Assurance team working on special projects.

• Participate on permanent and temporary teams which are process or project driven.

• Become familiar and subject matter expert on electronic support systems, TrackWise, TeamCenter, SAP, ADMS, etc.

• Collect analysis and publish quality metrics.

 

Required Qualifications

• Bachelor’s Degree.

• Direct experience in a Quality or Regulatory Affairs role in a GMP related industry.

 

Preferred Qualifications

• Minimum 2 years of related experience.

• Demonstrated technical competency and working technical knowledge and application of concepts, practices, and procedures.

• Previous experience in Quality, CAPA, risk management and/or complaints.

• Previous experience in medical device industry.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

 

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$56,700.00 – $113,300.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

HIAC Core Lab

        

LOCATION:

United States > Irving : LC-02

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you.

CLA is dedicated to building a culture that invites different beliefs and perspectives to the table, so we can truly know and help our clients, communities, and each other.

Our Perks:

• Flexible PTO (designed to offer flexible time away for you!)

• Up to 12 weeks paid parental leave

• Paid Volunteer Time Off

• Mental health coverage

• Quarterly Wellness stipend

• Fertility benefits

• Complete list of benefits here

CLA  is currently seeking an Assurance Senior to join our Audit & Assurance practice, in New Jersey. CLA has one of the largest nonprofit practices in the country with more than 60 years of experience in the industry. Our nonprofit industry team is composed of more than 500+ professionals servicing our 9,000 nonprofit clients. This position will be based out of our Livingston or Woodcliff Lake, NJ, offices, and is hybrid.

How you’ll create opportunities in this Senior Audit Associate role:

• Executing and managing the day-to-day activities of audit engagements with business clients from start to finish alongside Firm leadership. This includes managing the budget, planning, fieldwork, directing staff and completing financial statements, including related disclosures.

• Reviewing client accounting and operating procedures

• Developing and assessing the design and implementation of internal controls

• Preparing all necessary financial statement and related disclosures and reportable condition correspondence letters

• Utilizing proactive and effective communication with staff, management, and clients to communicate technical matters to both clients and management.

What you will need:

• Bachelor’s degree in Accounting or related field is required.

• Current CPA or eligibility to sit for the CPA exam is required.

• Two years of public accounting experience with emphasis in financial statement preparation, audits, reviews, and compilations is required.

• Prior experience with an established public accounting or professional services firm is preferred.

• Ability to travel to client sites which may also require infrequent overnight travel.

#LI-BV1

Equal Opportunity Employer /AA Employer/Minorities/Women/Protected Veterans/Individuals with Disabilities.
 
Click here to learn about your hiring rights.

Wellness at CLA

To support our CLA family members, we focus on their physical, financial, social, and emotional well-being and offer comprehensive benefit options that include health, dental, vision, 401k and much more.

To view a complete list of benefits click here.

Job Description Summary

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

As a Senior Quality Specialist at BD, you will be a key driver in ensuring the robustness and effectiveness of our Quality Management System. You will play a pivotal role in managing CAPA processes, conducting internal and external audits, integrating quality systems, and ensuring compliance with industry regulations.

 Key Responsibilities:

1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring. Ensure timely and effective resolution of quality issues.

2. Audit Coordination: Plan, conduct, and manage internal and external audits to evaluate the adherence to quality standards, regulations, and QMS procedures. Prepare audit reports, identify non-conformities, and guide corrective actions.

3. Quality System Integration: Collaborate with cross-functional teams to integrate quality management systems across various departments. Streamline processes, eliminate redundancies, and ensure consistency in quality practices.

4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards. Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes.

5. Documentation Control: Oversee the management of QMS documentation and records, ensuring accuracy, version control, and compliance with document control procedures.

6. Continuous Improvement: Lead and participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards.

7. Training and Development: Provide training and mentorship to junior quality specialists, ensuring their growth and development within the organization.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences).

• Minimum 7 years of experience in quality management with a focus on CAPA, audits, quality system integration, and regulatory compliance.

• Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP).

• Proficiency in CAPA software and auditing tools. (e.g. Trackwise)

• Demonstrated experience in leading and participating in internal and external audits.

• Excellent analytical, problem-solving, and communication skills.

• Certification in Quality Management (e.g., Certified Quality Auditor) is a significant advantage.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

PDN

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.  We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$96,600.00 - $159,300.00

Quality Assurance Specialist

The Opportunity: 

When a user tries a new system, they expect it to be intuitive and run smoothly. Functionality, reliability, and user experience are key to successful information systems—and that means rigorous testing. That’s why we need you, a quality assurance analyst who’s eager to help thoroughly test software and ensure that our team releases the best system possible.   

As a quality assurance consultant on our team, you’ll work with developers, user experience (UX) specialists, and other team members to evaluate developed systems for the client. You’ll help develop and implement a test plan based on requirements and functional and design specifications, as well as support system deployments.   

Using software quality assurance, you’ll generate problem resolutions and track quality assurance standards to observe how the system performs, then document the results and communicate defects to the development team so they can start improving the tool. You’ll expand upon your experience in various types of testing, including manual, performance, and accessibility testing. This is an opportunity to broaden your skills in documenting and solving system deficiencies as well as applying Agile practices and using automated testing tools.

Join us. The world can’t wait.

You Have:

• Experience with quality assurance on a software development project

• Experience with business analyst activities

• Experience with using Microsoft Office, including Excel

• Experience with Agile development and working closely with developers to provide collaborative feedback

• Ability to work with different teams across organizations to present and communicate analytical findings on an independent basis

• Ability to collaborate with team members on a regular basis

• Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements

• Bachelor's degree

Nice If You Have:

• Experience with automated testing tools, including Selenium and Specflow in Gherkin

• Experience with XML and API Stacks

• Experience with Section 508 compliance standards and testing tools

• Experience with C#

• Ability to manage the prioritization of multiple tasks

• Possession of strong problem-solving skills, including independently and collaboratively

• Possession of strong organizational skills

• Possession of strong interpersonal skills

Vetting:
Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client.

Create Your Career:

Grow With Us

Your growth matters to us—that’s why we offer a variety of ways for you to develop your career. With professional and leadership development opportunities like upskilling programs, tuition reimbursement, mentoring, and firm-sponsored networking, you can chart a unique and fulfilling career path on your own terms.

A Place Where You Belong

Diverse perspectives cultivate collective ingenuity. Booz Allen’s culture of respect, equity, and opportunity means that, here, you are free to bring your whole self to work. With an array of business resource groups and other opportunities for connection, you’ll build your community in no time.

Support Your Well-Being

Our comprehensive benefits package includes wellness programs with HSA contributions, paid holidays, paid parental leave, a generous 401(k) match, and more. With these benefits, plus the option for flexible schedules and remote and hybrid locations, we’ll support you as you pursue a balanced, fulfilling life—at work and at home.

Your Candidate Journey

At Booz Allen, we know our people are what propel us forward, and we value relationships most of all. Here, we’ve compiled a list of resources so you’ll know what to expect as we forge a connection with you during your journey as a candidate with us.

Compensation

At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen’s benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page.

Salary at Booz Allen is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $58,400.00 to $133,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen’s total compensation package for employees.

Work Model
Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely.

• If this position is listed as remote or hybrid, you’ll periodically work from a Booz Allen or client site facility.
• If this position is listed as onsite, you’ll work with colleagues and clients in person, as needed for the specific role.

EEO Commitment

We’re an equal employment opportunity/affirmative action employer that empowers our people to fearlessly drive change – no matter their race, color, ethnicity, religion, sex (including pregnancy, childbirth, lactation, or related medical conditions), national origin, ancestry, age, marital status, sexual orientation, gender identity and expression, disability, veteran status, military or uniformed service member status, genetic information, or any other status protected by applicable federal, state, local, or international law.

Key Responsibilities

• Demonstrates intermediate knowledge and skills within Quality tools and methods and Training for FSO. 
  Provide & participate various training to AMAT employees, supplier, customers as needed.
  Receives a moderate level of guidance and direction
• Work with the field service focal person and the customer to fully understand the issue
  Assume as primary focal responsible for driving corrective action and proactively resolving issues
• Facilitate monthly/quarterly reviews with the customer quality team and GM of the Field Service Organization to review the performance of key factors that drive the success/failure of Key Performance Indicators
  Gather solutions, such as the Supplier Corrective Action Requirement (SCAR) to fill gaps in performance
  Capture the voice of external customers by working with the GM of the Account Team to develop KPIs and metrics/measurement standards
• Coorindate issue resolution using quality tools (Trackwise, Advanced Problem Solving (APS), and statistical analysis tools)
  Work closely with Customer Engineers (CEs) and cross functional teams to identify root cause and establish corrective actions
  Coordinate closure based on findings from the FA report
• Work with internal teams to prepare for QMS reviews
  Maintain quality processes as necessary to comply with QMS requirements
  Document the variations of the global QMS as required to meet country-specific needs
  Prepare the local groups for the ISO certification audit
  Conduct ISO pre-audits with supervison
• Proficieny in APS methodolgy
  Define and implement corrective actions with supervision
  Identify the systems, processes, practices and procedures that need to be modified to prevent recurrence of this and all similar problems
• Determine Systamatic High Volume problem to help improve field Quality

Functional Knowledge

• Demonstrates conceptual and practical expertise in own discipline and basic knowledge of related disciplines

Business Expertise

• Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

Leadership

•  Acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements

Problem Solving

• Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information

Impact

• Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies

Interpersonal Skills

• Explains difficult or sensitive information; works to build consensus

Qualifications

Education:

Bachelor's Degree

Skills

Certifications:

Languages:

Years of Experience:

4 - 7 Years

Work Experience:

Additional Information

Travel:

Yes, 25% of the Time

Relocation Eligible:

Yes

U.S. Salary Range:

$92,000.00 - $126,500.00

The salary offered to a selected candidate will be based on a number of factors including location and level and will vary depending on confirmed job-related knowledge, skills, and experience.  In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable.

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. 

Applied Materials, Inc. is the global leader in the Engineering and Manufacturing of Capital Equipment for the Semiconductor industry.   Applied Materials' Ion Implanter Business Unit (VSE) is searching for a Manufacturing Quality Engineer to join our growing team in support of our Newburyport and Gloucester MA locations.

Working in our Quality Group in a Manufacturing environment, the position will entail the following:

• Analyzes quality performance data and metrics to identify improvement opportunities and drive improvements.
• Investigates root causes of defective material through visual inspection, historical research, and general troubleshooting investigation.
• Develops containment plans for defective parts and helps drive systemic corrective actions to prevent reoccurrence through collaborations with cross-functional teams.
• Utilizes SAP, our Enterprise-Wide Application, to facilitate the flow of defective material in MRB (Material Review Board), from its arrival to its disposition.
• Engages with Manufacturing to continue to improve processes to ensure Quality standards understood and met on order to exceed Customer expectations. 
• Develops, applies, revises, maintains and/ or tests quality/ reliability standards to ensure alignment with customer expectations.
• Evaluates work methods, procedures and policies to ensure world class quality standards are attainable.
• May be accountable for projects/ programs as wells as developing methods and parameters, project methodology and/ or project proposals.
• Works closely with Engineering and Manufacturing to ensure consistent execution of new product roll out.
• May assist Supplier Quality Engineers with supplier audits and focused improvement activities.
• Work in collaboration with our Singapore based Quality and MFG teams to help adopt BKM’s and drive continuous improvement projects between sites.

What We're Looking For

At Applied Materials- VSE, the Manufacturing Quality Engineer will have the opportunity to create real solutions to improve Manufacturing & Quality processes that will leave a lasting impact. The Quality Team is looking for a candidate who has a background in Mechanical, Electrical or Quality Engineering who demonstrates the following characteristics:

• Driven, persistent, curious, and tenacious in solving problems
• Systematic data-driven approach to problem solving
• Has strong interpersonal skills and enjoys working with cross functional-teams
• Strong communication skills
• Enthusiastic and eager to learn

Functional Knowledge

• Works on issues where analysis of situation or data requires review of relevant factors.

Business Expertise

• Receives assignments in the form of objectives with goals and the process by which to meet goals. Recommends changes to unit or sub-unit policies. Management reviews work to measure meeting of objectives.

Leadership

• Provides direction to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees.

Problem Solving

• Exercises judgment within defined procedures and policies to determine appropriate action.

Impact

• Erroneous decisions or failure to achieve results will cause delays in schedules.

Interpersonal Skills

• Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

Position requires understanding of Applied Materials global Standards of Business Conduct and compliance with these standards at all times. This includes demonstrating the highest level of ethical conduct reflecting Applied Materials' core values.

Qualifications

Education:

Bachelor's Degree

Skills

Certifications:

Languages:

Years of Experience:

4 - 7 Years

Work Experience:

Additional Information

Travel:

Yes, 10% of the Time

Relocation Eligible:

No

U.S. Salary Range:

$92,000.00 - $126,500.00

The salary offered to a selected candidate will be based on a number of factors including location and level and will vary depending on confirmed job-related knowledge, skills, and experience.  In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable.

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. 

Key Responsibilities

1. Develops, applies, revises, maintains and/ or tests quality/ reliability standards to ensure alignment with customer expectations.
2. Designs and implements methods and procedures for inspecting, testing and evaluating the quality/ reliability of products
3. Develops, implements quality/ reliability test plans and performs failure analysis.
4. Gathers operational and test data and evaluates results.  Prepares documentation for testing.
5. Develops methods and parameters, project methodology and/ or project proposals.
6. Evaluates work methods, procedures and policies to ensure world class quality standards are attainable.
7. Perform FMECA, document CRAMS and work with supplier and engineer to enable crams test plan. Also perform PQP at supplier.

Functional Knowledge

• Demonstrates expanded conceptual knowledge in own discipline and broadens capabilities

Business Expertise

• Understands key business drivers; uses this understanding to accomplish own work

Leadership

• No supervisory responsibilities but provides informal guidance to new team members

Problem Solving

• Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents 

Impact

• Impacts quality of own work and the work of others on the team; works within guidelines and policies

Interpersonal Skills

• Explains complex information to others in straightforward situations

Qualifications

Education:

Bachelor's Degree

Skills

Certifications:

Languages:

Years of Experience:

1 - 2 Years

Work Experience:

Additional Information

Travel:

Yes, 10% of the Time

Relocation Eligible:

No

U.S. Salary Range:

$72,000.00 - $99,000.00

The salary offered to a selected candidate will be based on a number of factors including location and level and will vary depending on confirmed job-related knowledge, skills, and experience.  In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable.

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. 

Number of Job Openings Available:

1

Date Posted:

November 20, 2023

Department:

16002240 Regional Safety and Quality

Shift:

Day (United States of America)

Shift Length:

8 hour shift

Hours Per Week:

40

Union Contract:

Non-Union

Weekend Rotation:

None

Job Summary:

Provides regulatory program support at the business unit level. Partners with site teams to analyze and operationalize accreditation, certification, and regulatory requirements to ensure compliance, and incorporate high-reliability principles and tools into these efforts. Partners with colleagues to lead the development, implementation and evaluation of site accreditation, certification, and regulatory initiatives. Supports data analysis, gap assessments, and presentations related to priority accreditation, certification, and regulatory standards, as well as processes and projects at the site level. Partners with Physician and Clinical and Operational Leaders to mobilize teams to improve compliance with accreditation, certification, and regulatory standards to optimize patient outcomes.

Key Position Details:

• Will support St. Francis, New Ulm, Owatonna and Faribault
• No weekend rotation
• Benefit Eligible

Job Description:

Principle Responsibilities

• Participates in system and site policy and procedure development, revision and implementation to ensure alignment with accreditation, certification, and regulatory standards.
  • Assists in identifying existing and needed processes and procedures and supports policy updates.
  • Supports teams to develop or revise policies and procedures.
  • Collaborates with key stakeholders to reliably implement policies and procedures in alignment with safety and quality principles and practices.
• Possesses and provides entry-level knowledge in accreditation, certification, and regulatory to perform tasks and address problems.
  • Serves as a resource to ensure accreditation, certification, and regulatory compliance.
  • Assesses and analyzes accreditation, certification, and regulatory requirements and compliance.
• Partners with colleagues to develop and implement processes to meet accreditation, certification, and regulatory standards, reduce duplication of efforts and gain efficiency in the program.
  • Guides site accreditation, certification, and regulatory processes including internal surveys, application updating, system contracts, and internal tracers.
  • Supports a sustainable approach to compliance.
  • Participates in internal surveys.
  • Participates in external regulatory surveys.
• Assists colleagues to provide guidance and support to business unit leadership, clinical and departmental teams in functional area.
  • Incorporates HRO principles and improvement tools into accreditation, certification, and regulatory project implementation and sustainment.
  • Uses problem-solving skills from work experience and applies these skills to support stakeholders in decision-making.
  • Other duties as assigned.

Job Requirements

• Bachelor's degree Nursing, Public Health, Pharmacy, Health Care Administration, Engineering or other health care related field required required
• 0 to 2 years experience in accreditation, certification, and/or regulatory required (actively leading survey readiness or formal accreditation, certification, regulatory role) required and
• 2 to 5 years healthcare experience in related field required

Physical Demands
Sedentary:
Lifting weight Up to 10 lbs. occasionally, negligible weight frequently

Key Responsibilities

• Develops and applies quality standards in accordance with company and customer requirements. Develops and conducts related tests.
• Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/ or production equipment.
• Develops methods and parameters, project methodology and/ or project proposals.
• Develops and uses procedures.  Prepares documentation for inspection/ testing procedures. Recommends corrective action for procedural, product, or process deficiencies.
• Gathers operational and test data and evaluates results. 
• Evaluates work methods, procedures, and policies. Tracks progress of qualification status, reviews reliability test results, determines disposition of non-compliant products, reviews and releases qualification packs.  Participates in audits.
• Utilizes drawings, specifications, industry standards, and sketches, adapting inspection measuring devices and procedures when necessary. Read and interpret technical drawings and specification requirements. 
• Reduces qualification cycle time and cost while still meeting quality performance requirements.
• Functional Knowledge

• Demonstrates expanded conceptual knowledge in own discipline and broadens capabilities.
• Works across Business Units and functional groups to engage the right people to provide expertise to solve problems rapidly.
• Functions in manufacturing, logistics, and supplier environments to provide quick resolution of part quality issues through rework or replacement.
• Draft and upgrade Quality Management System documents as needed.

Business Expertise

• Understands key business drivers; uses this understanding to accomplish own work.

Leadership

• No supervisory responsibilities but provides informal guidance to new team members.

Problem Solving

• Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents. 
• Able to understand and apply technical specifications, manufacturing build and test methods, and customer requirements for all Applied Materials products.

Impact

• Impacts quality of own work and the work of others on the team; works within guidelines and policies.

Interpersonal Skills

• Explains complex information to others in straightforward situations. #LI

Qualifications

Education:

Bachelor's Degree

Skills

Certifications:

Languages:

Years of Experience:

7 - 10 Years

Work Experience:

Additional Information

Travel:

Yes, 10% of the Time

Relocation Eligible:

No

U.S. Salary Range:

$108,000.00 - $148,500.00

The salary offered to a selected candidate will be based on a number of factors including location and level and will vary depending on confirmed job-related knowledge, skills, and experience.  In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable.

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. 

Job Summary

Avantor, a Global Fortune 500 company is looking for a dedicated Global Quality Risk Manager to optimize our Quality organization.  This Radnor, PA based role is full-time.

If you have Quality/ Risk Management experience – let’s talk!

Minimum Education:

• Bachelor's degree in a technical or engineering discipline 

Required experience (2+ years):

• Maintaining the risk management process including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk Reduction.
• Quality assurance experience in the pharmaceutical industry
• Managing 21 CFR 210 and 211, ISO 13485 and ISO 14971 requirements. 
• Leading the risk management activities for assigned projects and establish system risk documentation (risk management plans and reports, post market risk evaluation etc.)
• Coordinating across functional teams in the development & execution of design risk analyses for design plans, design reviews, dFMEA, pFMEA and uFMEA.
• Advising R&D on risk management associated with corrective & preventive actions (CAPA)
• Identifying risk areas for imported & distributed devices (transport, storage, warehouse conditions, etc.) and develop risk mitigation plans.
• Risk mitigation plan execution
• Authoring corporate risk management procedures.

Preferred Experience:

• Managing product risk across the QMS (i.e.: field actions, complaint trending, vigilance & PMS data).
• Performing risk assessment as part of post-market monitoring in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and supplier risk assessment evaluation and manufacturing non-conforming materials
• Cross functional team experience
• Analytical and problem-solving application skills
• Project management

How you will thrive and create an impact:

The Global Quality Risk Manager will drive continuous improvement efforts through facilitating, leading, and collaborating with cross functional teams.  This subject matter expert will support risk management audits, when working with external business partners and regulatory authorities.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.  

The work we do changes people’s lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom’s voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.  

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world.

Apply today!

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

EEO Statement:

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Charter

Prevent Quality excursions from reaching our customers driving from Product Quality improvements in Manufacturing to Final Test, launch product risk screens, launch CAPA, SCARs and proliferating lessons learned while collaborating with multiple functional teams, negotiating their priorities to address DDP's product line needed improvements.

Key Responsibilities - Hardware Quality Engineering opportunity, No Relo

Hardware Manufacturing Customer Experience Quality Engineering position Develops and applies quality standards in accordance with company and customer requirements.

• Develops and conducts related tests. Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/ or production equipment using AMAT internal application tools.
• Develops methods and parameters, project methodology and/ or project proposals. Develops and uses procedures.
• Prepares documentation for inspection/ testing procedures. Recommends corrective action for procedural, product, or process deficiencies. Gathers operational and test data and evaluates results.  Evaluates work methods, procedures and policies. Tracks progress of qualification status, reviews reliability test results, determines disposition of non-compliant products, reviews and releases qualification packs.  Participates in audits. Utilizes drawings, specifications, industry standards, and sketches, adapting inspection measuring devices and procedures when necessary. Read and interpret technical drawings and specification requirements. Reduces qualification cycle time and cost while still meeting quality performance requirements. Responsible for driving Continuous Improvement in the Quality of AMAT’s product portfolio Eliminate customer complaints and escalations Work and demonstrate ability to closely lead multi-functional teams including but not limited to: experienced design and development engineers, Quality and Reliability engineers, Supply Chain Management teams, suppliers and technology partners in order to acquire and implement best known methodologies and deliver a better quality and customer experience than in current portfolio. Monitor field customer performance of product to identify issues and allow for early investigation and mitigation Drive investigation, capture, Root Cause Analysis, Containment, Corrective Action, Process Improvement to prevent issue recurrence, Monitor plans using statistical methods Conduct Quality Post-Mortem and document lessons learned reviews from current and older products to prevent recurrence of Quality issues and drive corrective actions into the next generation product portfolio Drive customer escalation resolution (root cause analysis, Containment, Corrective Action and Process Improvements following the 8D discipline format) to prevent recurrence of problems

Drive Design, Quality, Reliability, lessons learned and VoC (Voice of Customer) requirements into new product designs to improve the quality and reliability of new products.

Functional Knowledge

• Demonstrates expanded conceptual knowledge in own discipline and broadens capabilities
• Strong computer skills, Microsoft Office applications (Excel proficiency required), Power BI
• 8D Root Cause analysis and Corrective Action, Containment, Prevention, Proliferation measures, FMEA, DMAIC, Green Belt Certified or equivalent, Analytical tools (Paretos, Histograms, Ishikawa (Six Elements), Scatter, Control charts, checklists)

Business Expertise and Skills

• Understands key business drivers; uses this understanding to accomplish own work
• Experience in high volume manufacturing environments
• Proven track record working and managing customer issues and suppliers Key Performance Indicators (KPIs)
• Manage and coordinate customer PPM (Parts per Million), supplier PPM, supplier problem solving on time, cost recovery and supplier warranty indicators
• Knowledge of Quality systems and measurements, Lean Manufacturing, Advanced Product Quality Planning (APQP), Product Part Approval Process (PPAP), PFMEA, ISO9001, Quality Assurance tools
• Undertake special projects as required
• Lead, Contribute and support continuous improvement activities
• Prepare and present reports at group meetings and internal customers
• Understanding of engineering drawings and manufacturing processes
• Ability to work in a diverse and dynamic environment
• Planning and prioritizing activities
• Good communication and interpersonal skills
• Negotiation and Influencing skills
• Ability to present data effectively
• Problem-solving skills
• Team working skills
• Analytical skills
• Time management
• Understanding of cost and financial impacts

Leadership

• No supervisory responsibilities but provides informal guidance to new team members
• Self-motivated individual, Flexible, Adaptable. Optimistic, Self aware, Open to change
• Work mostly with minimal supervision Assertive, resilient and welcomes change and navigates through adversity
• Shows moral courage, openness and honesty in all dealings
• Engages interest and participation of others and has a collaborative approach to working with others
• Lead, support groups of technicians and engineers
• Training skills, provide guidance and coach other team members

Problem Solving

• Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents 
• Excellent attention to detail
• Continuous improvement consultant skills
• Lean Manufacturing knowledge
• Innovate from original solutions
• Works to build consensus

Impact

• Impacts quality of own work and the work of others on the team and external functional teams; works within guidelines and policies

Interpersonal Skills

• Explains complex information to others in straightforward situations

Travel:

• 0– 15%

Education

• Bachelor's Degree – Engineering, Computer Science or related Engineering Technology
• Advanced Quality Certifications
• 6 - 9 + Years of Experience job related

Applied Materials is committed to diversity in its workforce including Equal Employment Opportunity for Minorities, Females, Protected Veterans and Individuals with Disabilities.

Qualifications

Education:

Bachelor's Degree

Skills

Certifications:

Languages:

Years of Experience:

4 - 7 Years

Work Experience:

Additional Information

Travel:

Yes, 10% of the Time

Relocation Eligible:

No

U.S. Salary Range:

$92,000.00 - $126,500.00

The salary offered to a selected candidate will be based on a number of factors including location and level and will vary depending on confirmed job-related knowledge, skills, and experience.  In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable.

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law.