Quality Assurance Manager

Job Category: Engineering

Time Type: Full time

Minimum Clearance Required to Start: TS/SCI

Employee Type: Regular

Percentage of Travel Required: Up to 10%

Type of Travel: Continental US

What You’ll Get to Do:

• Produce and monitor compliance with the Program’s Quality Assurance Plan

• Provide Mission Assurance Services

• Monitor all aspects of the program from development to delivery to ensure quality planning and control.

• Monitor and report compliance with engineering processes and controls.

• Monitor software releases and track defects.

• Monitor configuration management controls and implementation.

• Ensure compliance with applicable industry quality standards.

You’ll Bring These Qualifications:

• TS/SCI Clearance

• Bachelor’s degree and 3+ years of experience

• Possess strong testing skills and experience with web applications, supporting functional, accessibility and regression testing requirements.

• Experience with web application testing in a production environment.

• Ability to work with standard software testing best practices, writing, and updating technical testing documentation.

• Documented experience of software testing tools and processes.

• Experience developing repeatable test procedures, executing test scripts and documenting results.

• Must be comfortable working with software developers to identify and resolve defects.

• Proven work experience in software development and quality assurance

• Strong existing knowledge of software QA methodologies for standard web applications, tools and processes and ability to learn new software and technologies as necessary.

• Experience in writing clear, concise, and comprehensive test plans and test cases.

• Works collaboratively with leads, developers, project managers, and graphics teams.

These Qualifications Would be Nice to Have:

What We Can Offer You:

- We’ve been named a Best Place to Work by the Washington Post.

- Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives.

- We offer competitive benefits and learning and development opportunities.

- We are mission-oriented and ever vigilant in aligning our solutions with the nation’s highest priorities.

- For over 60 years, the principles of CACI’s unique, character-based culture have been the driving force behind our success.

Company Overview: At CACI, you will have the opportunity to make an immediate impact by providing information solutions and services in support of national security missions and government transformation for Intelligence, Defense, and Federal Civilian customers. CACI is an Equal Opportunity/Affirmative Action Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other protected characteristic. 

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.   

What You Will Achieve

This position will support the Pfizer Sanford, NC Quality Assurance department by serving as the champion for the site Inspection Readiness program; is assigned oversight and sponsorship of the overall site approach and is actively engaged in managing and strengthening Inspection Readiness and accountability for Inspection Readiness at the site through plan development, structure and implementation, education, awareness and reporting.  You will serve as the point of contact and be accountable to facilitate appropriate site-based initiatives to ensure effective rollout of the Inspection Readiness program.  Engaging, communicating, and influencing site colleagues will be instrumental in achieving a quality culture aligned around the importance of achieving success in this role.    

As a Quality Assurance Manager, your knowledge and skills will contribute towards the goals and objectives of the site.  Your focus and ability to define and meet targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

How You Will Achieve It

• Develop, manage, and execute the site Inspection Readiness program and the Sanford site.

• Work with site leadership and partner with center colleagues to develop and maintain a robust site strategy, including action plans and tracking to ensure the site is inspection ready at all times.

• Identify Quality risks and track, report on and facilitate mitigation of identified risks as it pertains to Inspection Readiness.

• Provide guidance, mentor others, lead/co-lead projects, manage own time to meet objectives and plan projects across the Department.

• Drive effective management of quality issues and make decisions that may involve complex quality and technical issues.

• Communicate with and influence internal and external customers to ensure compliant and aligned resolution of project related issues.

• Align expectations across and above site as it pertains to Inspection Readiness activities and oversight.

• Contribute to Quality Assurance by undertaking a variety of roles and assignments to further develop internal processes and people.

Qualifications

Must-Have

• High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's degree in Science or Engineering with 8 years of experience OR a Bachelor's degree in Science or Engineering with at least 5 years of experience OR Master's Degree in Science or Engineering with more than 3 years of experience, OR a PhD with 0+ years of experience.

• Relevant pharmaceutical experience (Quality Operations)

• Ability to lead and drive projects/initiatives to completion

• Strong oral and written communication skills

• Able to work and contribute effectively in cross-functional team, culture differences, diversity.

• Experience with conducting gap assessment and system and process risk assessments.

• Familiar with quality auditing.

• Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity

• Demonstrated cGMP experience with compliance issues

• Proactive approach and strong critical thinking skills

• Project Manager, team leader/project leader or coach

• Strong verbal and written English communications capabilities

Nice-to-Have

• Demonstrated previous experience in problem solving, decision making, negotiating and conflict resolution skills

• Capability in Lean tools and/or desire to grow Lean capabilities to further drive Continuous Improvement projects.

• Functional knowledge of Microsoft SharePoint and Office applications, particularly Excel

Physical / Mental requirements

• Must be able to stand or walk for an extended period of time.

Non-Standard work schedule, travel or environment requirements

• Minimal travel

• Role will require after hour and weekend support from time to time.

Other job details

• Last day to apply: October 9th, 2023

• Employee Referral Bonus

• Relocation support available

Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

Manufacturing

The Quality Assurance Manager ensures the quality of product and services provided by the company. This position is responsible for managing quality assurance programs and the quality assurance department. This position is also responsible for monitoring and completing written reports, performing audits and completing product testing.

Duties and Responsibilities:

• Ensures the quality of product and services by testing product, performing audits of product lines, placing defective products on hold and taking corrective action
• Manages quality assurance programs and department by upholding quality programs expectations and standards scheduling personnel and shipments,
• Functions as primary SQF practitioner  and is responsible for food safety and validating and verifying that  SQF programs are in place and being enforced
• This position is responsible for administering the department’s budget to ensure proper allocation of resources
• Responsible for supervising direct reports
• Overseeing sanitation programs and performing other duties as assigned
• Performs other duties including but not limited to handling customer complaints, communicating holds and discrepancies with supervisors and other departments; completing various reports by maintaining bill of materials, maintaining hold logs, completing weekly and monthly reports
• Responsible for implementing Food Safety and Quality Systems

Minimum Job Requirements:

Education/Certifications:

• Bachelor’s degree in a science field, preferably food science
• Must have a valid driver’s license
• SQF Practitioner Cert
• PCQI Cert

Experience:

• Prefer five (5) years of quality assurance experience
• Minimum of five (5) years of management experience required
• Experience working with and upholding large national accounts standards
• Prefer experience in a bakery/dry mixing (dry blending, frozen doughs and batter products) production environment

Knowledge, Skills and Abilities:

• Excellent communication and coaching skills
• Detail oriented and organized
• Strong background in sanitation principles and practices
• Proficient  computer skills in spreadsheets; data bases and word processing
• Excellent technical knowledge of equipment, products and processes
• Self motivated, results orientated and excellent personal skills
• Strong background in HAACP; safety; GMP; AIB and SPC
• Must have a hands-on work ethic
• Global quality standards (SQF/BRC) experience preferred
• Bilingual a plus

Supervisory Responsibilities:

• Responsible for associates that report to the Quality Assurance and Quality Control departments. Monitoring associate performance, providing input on hiring, disciplinary actions, work objectives and their effectiveness, and realigning associates as needed.

Working Conditions and Physical Effort:

• Work involves daily exposure to unusual elements such as dirt, dust, fumes, darkness and/or noise. Seasonal exposure to weather elements includes, but is not limited to, extreme temperatures, wetness and humidity.
• Work environment involves daily exposure to physical risks such as working around mechanical equipment, forklifts, chemical hazards, and electrical hazards.
• Position requires the ability to stand, sitting frequently at a desk, walking around the office and plant; carrying packages up to 50 pounds; utilizing fine dexterity; reaching and kneeling on a daily basis. Also requires the ability to see, hear and communicate with associates as well as others by utilizing professional etiquette.
• Personal protective equipment, as defined by C.H. Guenther & Son, Inc. will be provided.

Expectations:

• Will demonstrate, promote and exemplify the Company’s Core Values in People, Quality and Growth.

We are proud to offer competitive compensation and benefit programs that include medical, dental, vision, flexible savings account, health savings account, 401K matching savings plan, employee assistance program, wellness programs, life insurance, AD&D insurance,  disability insurance, tuition reimbursement, student loan counseling, employee referral program, paid time off, and more! 

For additional information about our company, go to www.chg.com.

C.H. Guenther & Son and its subsidiaries are E-Verify participating employers.

Click here for more information regarding E-verify.

All offers of employment are contingent upon successful completion of the pre-employment screening process which includes a drug screen and review of criminal background and other records as required.

AA/EEO/Drug-Free Employer

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:

 

Sr. Supplier Quality Assurance Manager

Des Plaines

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 Des Plaines, IL Headquarters of Abbott Molecular, We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

This position provides leadership and guidance for the supplier quality engineering department; responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Daily responsibilities include managing the resolution of supplier quality/process issues, ensuring a continuous supply of high quality components to production and supporting product development to ensure the identification of quality oriented suppliers with capable processes that will manufacture high quality components. Ensures systems are in place to monitor and track department and supplier performance.

MAIN RESPONSIBILITIES

• Recruits, coaches and develops organizational talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Creates an entrepreneurial environment.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May supervise non-exempt employees.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).

• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. Lead / support proactive improvements at key suppliers
• Serve as technical supplier engineering resource for Third Party Manufacturers (TPMs) and critical / high-risk suppliers
• Ensure appropriate Quality Management System and process controls at the supplier / service providers to yield high quality material and products
• Identify and lead activities to reduce supplier related field actions and high-risk customer complaints / risk assessments

• Develops, monitors and appropriately adjusts the annual budget for department(s).
• Proactive Development of Supplier Management System

QUALIFICATIONS

Education

Bachelor’s degree Required.

Experience/Background

• Minimum 9 years’ experience /7 years of Management experience
• Related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or unit.
• Monitors company-wide indicators such as market share and profitability.
• Monitors external environment in area of technical or professional responsibility.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
• Facilitates others' participation in the continuous improvement program.
• Investigates and solves problems that impact work processes and personnel within or across units or departments.
• Develops and communicates a vision for the organizational unit assigned.

Apply Now

* 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

$118,000.00 – $236,000.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AMD Molecular

        

LOCATION:

United States > Des Plaines : DP01

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

     

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

• Designs/implements/maintains a risk-based surveillance program and assessment plan associated with the quality assurance provisions of contracts.
• Identifies opportunities for process improvements by analyzing data.
• As a member of a multi-functional or technical team, implements the overall Quality Program for diverse products and services to support the U.S. Government’s acquisition at one or more supplier facilities.
• Ensures contractor compliance with design, manufacturing, repair, overhaul, and modernization requirements.
• Independently audits/surveils contractor processes to ensure compliance with customer/contractual requirements.
• Investigates customer complaints/concerns about contractor quality performance and processes which impact user satisfaction, then provides data about the complaints.
• Provides technical support to DCMA team members, assisting with analyzing contractual issues, and determining the best course of action to support the contractor and customers.

Starting at $73,639 Per Year (GS 11)

• Analyzes performance data and determines the frequency needed to determine if performance goals/initiatives are met.
• Reviews contracts and other technical data to identify requirements in support of Production, Planning, and Control ensuring resources are aligned based on requirements.
• Utilizes various strategies to communicate Contract Management Office performance, engagement strategies, and customer information.
• Works with Human Capital Directorate ensuring team members are assigned to the correct Position Description.
• Provides technical interpretation of new and revised regulations, policies, and other releases.

Starting at $92,123 Per Year (GS 12)

• You will solve problems effectively by using objective data to generate conclusions. Identifies customers, both internal and external, and meets their needs.
• You will develop and/or makes changes to quality checklists for equipment being manufactured, assembled, or overhauled and resolve discrepancies when documentation is ambiguous or not complete
• You will set up, calibrate programs, and operate sophisticated computerized inspection equipment including coordinate measuring machines (CMM), tensile test machines, and emission analyzers.
• You will participate in engineering and quality investigations of equipment found to cause problems in the Fleet.
• You will perform miscellaneous minor duties as assigned.

Starting at $80,769 Per Year (GS 11-12)

• Works with the HR Supervisor(s) to ensure performance and ability to meet HR business requirements are established and implemented.
• Performs audits on human resources Client Services functions to ensure programs are operated in accordance with merit system principles.
• Audits coding of SF-50s Personnel Action Forms for processing. Reviews HR actions for the appropriate nature of action and authority codes, remarks, and effective dates.
• Prepare audit findings, consolidate information for review reports, and interpret reporting requirements and program instructions.
• Reviews and identifies correction of erroneous personnel actions using Federal statute, IHS policy and OPM guidance to ensure HR Specialist (Recruitment and Placement) staff correct actions to erroneous personnel actions in HR Recruitment and Placement.
• Identifies technical discrepancies in HR Client Services areas identifying the need for training, interventions and strategies that improve the HR staff's accuracy with processing and coding personnel actions.
• Provides HR staff with information, guidance and interpretation related to complex HR policies that require substantial research.
• Collaborates with HR Supervisor(s) and management in determining short- and long-term initiatives and project support needs and in developing effective HR Solutions methods and strategies for proactively researching, analyzing and resolving long standing systemic issues within the HR Operations processes.
• Develops and provides consultative services and authoritative advice to HR staff; managers, supervisors, and employees regarding very broad, difficult and complex HR issues involving the HR subject matter areas.

Starting at $69,107 Per Year (GS 11-12)

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more suppliers facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractors processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractors quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

Starting at $69,107 Per Year (GS 11)

• Plans, directs, and implements in-plant quality assurance programs for contracts assigned to the Contract Management Office (CMO).
• Guides, motivates, and oversees subordinates with a focus on project/program issues.
• Assumes ownership of processes and products as appropriate.
• Resolves diverse, highly complex problems across multiple areas and disciplines.
• Uses innovative approaches to resolve unusual and difficult issues that significantly impact important policies and programs.
• Anticipates problems, then develops solutions and action plans to ensure program/mission success.
• Completes multiple project and program goals within established guidelines.

Starting at $85,596 Per Year (NH 3)

• Administers quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data. Serves as a member of a multi-functional or technical team.
• Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more suppliers facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

Starting at $74,961 Per Year (GS 11)

• You will monitor the capability of the builder's processes, regularly audits their in-process execution, and inspects the final products produced.
• You will prepare and monitor surveillance plans, and sampling criteria, for the fabrication, installation, activation, testing and trials of numerous shipboard systems.
• You will plan and apply QA methods to audit and monitor the Contractor's QA system and processes; production, waterfront and storage facilities; industrial safety, fire and security programs; and varied contractual personnel qualification programs.
• You will monitor corrective actions undertaken to both assure the product delivered adheres to referenced standards, that corrective actions prove successful, and adequate to prevent recurrence.
• You will serve as a member of the Supervisor's MOCK INSURV Board, assessing the ship's readiness to operate during acceptance trials, and provide assessment and recommendations concerning delivery readiness, for the vessels under our purview.

Starting at $57,118 Per Year (GS 9-11)

H.B. Fuller is a leading global adhesives provider focusing on perfecting adhesives and sealants across all industries throughout the world. While our products are virtually invisible, they play a vital role in ensuring the quality of modern life and we are committed to connecting what matters to solve some of the world's biggest adhesion challenges.

Pay is based on several factors including but not limited to education, work experience, certifications, and geographic location.

The salary for this role is $66,057 - $86,700.

In addition to your salary, H.B. Fuller offers employees a competitive total rewards package including comprehensive benefits, incentive and recognitions programs, health & wellness benefits, 401K contributions, paid time off and paid holidays. Eligibility may vary.

H.B. Fuller is an Equal Employment Opportunity employer and proud to have created a collaborative culture where employees around the world are seen, heard, and respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, or marital status or status as a protected veteran, or any other legally protected classification.

H.B. Fuller does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with H.B. Fuller, a written service agreement must be executed by Human Resources prior to submitting any information relating to a potential candidate. Without a signed service agreement, H.B. Fuller shall not be obligated for payment of any fee or compensation.

• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Applies a wide range of methods, principles, and practices directly related to quality control/quality assurance fields; statistical analysis, control and sampling, quality data analysis and evaluation to determine contractor compliance.
• Incorporates a thorough and detailed QA knowledge in applying various methods and techniques for investigating, analyzing, and ensuring corrective action on complex quality problems.
• Develops and implements a surveillance plan which begins with clear objectives supported by a master schedule that includes identification of contractor and sub-contractor production needs.
• Performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.

Starting at $90,893 Per Year (GS 12)

• Serve as a Quality Assurance Specialist responsible for auditing contractor’s performance in accordance with the terms of the contract.
• Monitor contractor compliance with the contractor’s quality control system.
• Develop the standard operating procedures and processes tied to the training and management strategy for contracting officer representatives.
• Provide training to junior Quality Assurance Specialists and CORs in all areas related to QA and contract management matters.
• Perform duties in the lead instructor’s absence.
• Serve as the liaison between the installation and other agencies regarding quality aspects of contract support operations.
• Serve as a technical authority to the requiring activity on matters of contract quality assurance and surveillance.

Starting at $102,267 Per Year (GS 13)