Total 23 Quality Assurance / Control job vacancies in Cheras Business Centre

DUTIES & RESPONSIBILITIES:-

1.      To comply with the requirements of the Management System implemented in the organisation (HACCP, ISO 14001, BRC-IoP Packaging and FSC Chain of Custody)

2.      To be responsible for product safety, legality, regulatory compliance and quality system implemented.

3.      Coordinates laboratories or testing of products and as well as calibration for equipment used in a laboratory for the testing

4.      To ensure the process capability of all products are being monitored and controlled according to the requirements.

5.      To conduct training program on product defects, product knowledge and GMP requirements.

6.      To conduct testing for current product or new product (sample) and work together with Buss. Dev department

7.  To perform any other duties as assigned by the superior.

Perks & Benefits

• Commission and bonus
• Casual dress code
• Personal leave
• Personal development opportunities

DUTIES & RESPONSIBILITIES:-

1.      To comply with the requirements of the Management System implemented in the organisation (HACCP, ISO 14001, BRC-IoP Packaging and FSC Chain of Custody)

2.      To be responsible for product safety, legality, regulatory compliance and quality system implemented.

3.      Coordinates laboratories or testing of products and as well as calibration for equipment used in a laboratory for the testing

4.      To ensure the process capability of all products are being monitored and controlled according to the requirements.

5.      To conduct training program on product defects, product knowledge and GMP requirements.

6.      To conduct testing for current product or new product (sample) and work together with Buss. Dev department

7.  To perform any other duties as assigned by the superior.

Perks & Benefits

Commission and bonus
Casual dress code
Personal leave
Personal development opportunities

The Job

• Responsible for ensuring that each part of the manufacturing process has been correctly completed.
• To supervising the production process to make sure that all products meet consistent standards.
• To develop and implementing quality control tests, inspecting products at various stages and writing reports documenting production issues.

 

Responsibilities

• Ensure the effectiveness of the overall QA, ISO functions (ISO 9001 & ISO 14001) and other certifications (UL & CE) throughout the company.
• Ensure the effectiveness of document, drawing and information control system throughout the company.
• Ensure the effectiveness of quality improvement plans formulated from the review of customer complaint, internal rejection, supplier rejection, Corrective Action.
• Request (CAR) and Management Review.
• Ensure that quality management system/environmental management system is being maintained and continually improved.
• Liaise with the relevant Heads of Department to review and resolve all quality & environmental management system related issues.
• Conduct related quality/technical training to ensure highest competency and capability of the personnel concerned so as to ensure compliance to customer’s requirements.
• Ensure that internal audits, external audits and management review are periodically being carried out as per planned schedule.
• Ensure the measuring equipment calibration exercise is being updated as per planned schedule.

The Candidate

• Minimum Degree in Engineering (of any discipline) or Quality Management.
• 5 years experience in a managerial level in Quality Assurance and/or Quality Control.
• Minimum 3 years experience as a Management Representative for ISO 9001 QMS and/or ISO 14001 EMS.
• Qualified Lead Assessor for ISO 9001:2015 and/or ISO 14001:2015.
• Expert user of Microsoft Word, Excel and Power Point.
• Excellent command in English and Bahasa Malaysia
• Competent in reading, understanding and interpreting technical drawings.

Perks & Benefits

• Allowance (travel stipends, transportation, etc.)
• Regular team activities
• Medical insurance
• Personal leave
• Open culture
• Personal development opportunities

工作

• 負責確保製造過程的每個部分都正確完成。
• 監督生產過程，確保所有產品符合一致的標準。
• 制定和實施品質控制測試，檢查各個階段的產品並撰寫記錄生產問題的報告。

職責

• 確保整個公司整體品質保證、ISO 職能（ISO 9001 和 ISO 14001）以及其他認證（UL 和 CE）的有效性。
• 確保整個公司的文件、圖面和資訊控制系統的有效性。
• 確保透過審查客戶投訴、內部拒絕、供應商拒絕、糾正措施制定的品質改進計劃的有效性。
• 請求（CAR）和管理審查。
• 確保品質管理系統/環境管理系統得到維護並持續改進。
• 與相關部門主管聯絡，審查並解決所有品質和環境管理系統相關問題。
• 進行相關的品質/技術培訓，以確保相關人員具有最高的能力和能力，從而確保符合客戶的要求。
• 確保按照計畫時間表定期進行內部稽核、外部稽核和管理評審。
• 確保測量設備校準練習按照計畫時間表進行更新。

候選人

• 工程（任何學科）或品質管理的最低學位。
• 擁有 5 年品質保證和/或品質控制管理經驗。
• 至少 3 年作為 ISO 9001 QMS 和/或 ISO 14001 EMS 管理代表的經驗。
• ISO 9001:2015 和/或 ISO 14001:2015 的合格首席評估員。
• Microsoft Word、Excel 和 Power Point 的專家使用者。
• 精通英語和馬來語
• 能夠閱讀、理解和解釋技術圖。

津貼和福利

• 津貼（旅費、交通費等）
• 定期團隊活動
• 醫療保險
• 事假
• 開放文化
• 個人發展機會

, Poland

Job Family Group:

Finance

Worker Type:

Regular

Posting Start Date:

Business unit:

Finance

Experience Level:

Experienced Professionals

Job Description:

Controls Assurance Specialist (SOX internal controls)

Central Testing Excellence (CTE) Team is Shell’s centralized Line of Defense 2 (LOD2) function that helps to ensure Shell financial control framework is effectively managed. The Team provides independent assurance by testing design and operating effectiveness of internal controls over financial reporting (SOX and non-SOX) on behalf of Shell Management. By covering over 90% of all Shell SOX controls this global Centre of Expertise makes a significant contribution to Shell’s SOX compliance. The Team consists of risk and controls professionals with various experience levels and areas of specialisation.

The Controls Assurance Specialist (SOX internal controls) role supports the CTE Manager in coordinating the delivery of LOD2 management testing of financial controls for Shell. The testing is performed in line with a risk-based, annual testing plan developed in accordance with Shell Financial Control guidelines & and aligned with Sarbanes-Oxley requirements.

The role involves ensuring timely delivery of the plan, adherence to SOX attestation requirements, maintaining high-quality testing across all processes and business areas, and ensuring testing meets external auditor reliance requirements. The Controls Assurance Specialist performs testing of controls within complex accounting areas & processes, e.g. Tax, Financial Close process, Impairment, etc.

This is an individual contributor role and will support controls testing of Downstream R&A (Reporting & Analysis), Holdings & Treasury or Tax, Revenue processes /controls. The team consists of 8-10 SOX Testers with at various levels of experience, and is expected to contribute to overall Team delivery through individual testing but also through quality review, coordination of test planning, coaching & guidance to more junior Team members etc.

Accountabilities:

• Conducts financial control testing of internal controls, i.e. provides independent assessment of control design and operating effectiveness. Focuses on complex accounting areas (e.g. Tax, Manage Close process, Impairment, etc.) and external auditor management reliance.
• Supports CTE Manager in quality reviewing the controls testing performed by the Team.
• Helps to coordinate overall Team testing delivery, by managing changes to annual test plan, supporting QA/review process, coaching & guiding junior team members, monitoring status of delivery, addressing methodology queries, etc.
• Acts as subject matter expert in the area of SOX testing
• Documents the identified control deficiencies, and provides a risk-based impact & root cause analysis

Requirements:

• At least 5 years experience within Financial Audit, Internal Audit, and/or Risk & Controls Assurance is required. Experience within SOX compliance environment will be an advantage
• Experience in audit planning & executing design & operating effectiveness testing of internal controls within various business processes.
• Professional qualification in Accountancy / Audit / Internal Controls desirable (ACCA, Certified Internal Auditor CIA, CIMA, CISA or equivalent)
• Fluent English required as Team operates in a multi-location, virtual environment
• Experience in assurance transformation through digitalisation desirable (data analytics, automation, continuous controls monitoring)
• Risk based mindset, sound critical thinking around risks  & processes, ability to quickly absorb and digest new knowledge, cut through complexity and work independently with limited supervision
• Organised and self-driven, with collaborative way of working
• Strong influencing and interpersonal skills, including the ability to effectively work as a member of remote and multi-cultural virtual team

What we offer:

• Flexible working hours & hybrid set-up
• Complex medical care and individual life insurance
• Comfortable working environment: newly-built modern office with its own canteen, relax rooms, bike & car parking space
• Improved accessibility of office and sanitary facilities
• Attractive benefits package

If you don't see yourself fully reflected in every job requirement listed on the posting above, we still encourage you to reach out and apply. Research has shown that women and underrepresented groups often only apply when they feel 100% qualified. We are committed to creating a more equitable, inclusive and diverse company and we strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation, and life experiences to apply.

-

DISCLAIMER:

Please note: We occasionally amend or withdraw Shell jobs and reserve the right to do so at any time, including prior to the advertised closing date. Before applying, you are advised to read our data protection policy. This policy describes the processing that may be associated with your personal data and informs you that your personal data may be transferred to Shell/Shell Group companies around the world. The Shell Group and its approved recruitment consultants will never ask you for a fee to process or consider your application for a career with Shell. Anyone who demands such a fee is not an authorised Shell representative and you are strongly advised to refuse any such demand. Shell is an Equal Opportunity Employer.

03/29/2024

Address:

20 Erb Street West

Business Management

Will be working with RCM's to do Compliance and operations for Private Banking, Trust and Investments

Supports the business/group leader in the effective implementation, maintenance and administration of first line of defense (1st LOD) programs (e.g., operational risk, AML, compliance, regulatory, etc.), including overseeing business operations within the jurisdiction to ensure adherence and efficiency. Contributes to a strong risk management culture through collaboration with other first line employees, and second & third line functions to ensure Compliance, AML or operational risks are identified, mitigated, monitored and reported on an ongoing basis.

• Fosters a culture aligned to BMO purpose, values and strategy and role models BMO values and behaviours in all that they do.
• Ensures alignment between values and behaviour that fosters diversity and inclusion.
• Regularly connects work to BMO’s purpose, sets inspirational goals, defines clear expected outcomes, and ensures clear accountability for follow through.
• Builds interdependent teams that collaborate across functional and operating groups to create the highest value for all stakeholders.
• Attracts, retains, and enables the career development of top talent.
• Improves team performance, recognizes and rewards performance, coaches employees, supports their development, and manages poor performance.
• Supports multiple, similar business units with corresponding number of regulators.
• Assists with the implementation of risk management programs/ frameworks while identifying and minimizing negative impacts to the business.
• Develops and implements risk mitigation strategies.
• Acts as a subject matter expert in the evaluation, development and implementation of an internal control system.
• Supports the execution of strategic initiatives in collaboration with internal and external stakeholders.
• Builds effective relationships with internal/external stakeholders.
• Ensures alignment between stakeholders.
• Breaks down strategic problems, and analyses data and information to provide insights and recommendations.
• Monitors and tracks performance, and addresses any issues.
• Builds change management plans of varying scope and type; leads or participates in a variety of change management activities including readiness assessments, planning, stakeholder management, execution, evaluation and sustainment of initiatives.
• Monitoring to ensure that 1st line jobs are following defined processes and procedures.
• Develops, documents and maintains business/group procedures updating and obtaining approvals as regulations or the operating environment changes and communicates changes to the business/group & relevant stakeholder groups.
• Supports the development of measurable sustainment strategies including assessing and recommending mitigations for industry/ segment-specific risks and prioritizing opportunities presented by internal and external stakeholders.
• Tracks exception/exemption requests and corresponding approvals.
• Builds awareness, knowledge, and skills and, as necessary, provides communication, practical tools and ongoing support including making presentations, to promote a culture of risk identification and management.
• Supports the management of 1st LOD program for the business/group in compliance with appropriate principles, standards & direction from the second line of defense groups. Includes developing and promoting program and ensuring the execution of all program components.
• Works with assigned business/group leaders to implement 1st LOD programs and frameworks, developing and maintaining an in-depth understanding of the applicable regulatory and internal risk management requirements. Interprets and provides advice on the application of the requirements for the business/group.
• Develops and maintains an understanding of the business/group strategies and objectives, products and services, internal and external stakeholders and business processes as well as the underlying infrastructure to identify and manage implications and risk exposures for the business/group.
• Identifies, investigates, analyzes, documents & mitigates program risks, taking into account jurisdictional issues, and raises any issues or concerns to senior leaders and other stakeholders.
• Analyzes the impact and effectiveness of the program through periodic reviews.
• Recommends adjustments to the overall program, policy or processes within the business/group in accordance with the Risk Appetite Statement, Governance and Corporate Policy.
• Supports the business/group through internal/external audits or regulatory examinations and assists in development of action plans to resolve any identified issues.
• Provides support to the development and delivery of training and awareness programs within the business/group to increase awareness of and compliance to risk management requirements.
• Focus is primarily on business/group within BMO; may have broader, enterprise-wide focus.
• Exercises judgment to identify, diagnose, and solve problems within given rules.
• Works independently on a range of complex tasks, which may include unique situations.
• Broader work or accountabilities may be assigned as needed.

  Qualifications:

• Typically between 4 - 6 years of relevant experience and post-secondary degree in related field of study or an equivalent combination of education and experience.
• Program Management - Good.
• Technical proficiency gained through education and/or business experience.
• Verbal & written communication skills - In-depth.
• Collaboration & team skills - In-depth.
• Analytical and problem solving skills - In-depth.
• Influence skills - In-depth.
• Data driven decision making - In-depth.

$51,800.00 - $96,500.00

Salaried

The above represents BMO Financial Group’s pay range and type.

Salaries will vary based on factors such as location, skills, experience, education, and qualifications for the role, and may include a commission structure. Salaries for part-time roles will be pro-rated based on number of hours regularly worked. For commission roles, the salary listed above represents BMO Financial Group’s expected target for the first year in this position.

BMO Financial Group’s total compensation package will vary based on the pay type of the position and may include performance-based incentives, discretionary bonuses, as well as other perks and rewards. BMO also offers health insurance, tuition reimbursement, accident and life insurance, and retirement savings plans. To view more details of our benefits, please visit: https://jobs.bmo.com/global/en/Total-Rewards

We’re here to help

At BMO we are driven by a shared Purpose: Boldly Grow the Good in business and life. It calls on us to create lasting, positive change for our customers, our communities and our people. By working together, innovating and pushing boundaries, we transform lives and businesses, and power economic growth around the world.

As a member of the BMO team you are valued, respected and heard, and you have more ways to grow and make an impact. We strive to help you make an impact from day one – for yourself and our customers. We’ll support you with the tools and resources you need to reach new milestones, as you help our customers reach theirs. From in-depth training and coaching, to manager support and network-building opportunities, we’ll help you gain valuable experience, and broaden your skillset.

To find out more visit us at https://jobs.bmo.com/ca/en.

BMO is committed to an inclusive, equitable and accessible workplace. By learning from each other’s differences, we gain strength through our people and our perspectives. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request accommodation, please contact your recruiter.

Note to Recruiters: BMO does not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to BMO, directly or indirectly, will be considered BMO property. BMO will not pay a fee for any placement resulting from the receipt of an unsolicited resume. A recruiting agency must first have a valid, written and fully executed agency agreement contract for service to submit resumes.

Job Description

To assist in post-trade compliance, assist in the monitoring of the investment and transactional activities of fund managers to ensure compliance with regulatory and client-mandated investment guidelines.  You will also ensure that all client reporting are done accurately and on a timely basis. As our fund managers invest in a broad range of instruments, you should have some knowledge in various financial securities products.

Responsibilities

• Review and maintenance of accurate compliance rules across all fund types, in accordance with Investment guidelines or compliance parameters provided by client / fund manager.
• Ensure accurate and correct interpretation of guidelines and the creation of relevant rules in the compliance monitoring system.
• Ensure that alerts and / or breaches are monitored daily and follow-up action taken and documented. 
• Updating of Operating Procedures Manual and Operating Memorandums with clients.
• By adhering to guidelines and checklists, ensure that standard procedures and controls, as set out in the Operating Procedures Manual, are being adhered to. 
• Responsible for ensuring that all the daily / non-daily reporting to clients are met as per requirements.  
• Attend to client queries.
• Assist Funds Compliance Monitoring Manager in the smooth running of the compliance monitoring function of the department, including adherence to corporate and regulatory policies and requirements.
• Assist in process improvement initiatives. 
• Assist in training and development of new or inexperienced staff.
• Assist in user acceptance testing. 
• Working with internal/external parties (for example clients, fund managers, vendors, fund accountants, auditors etc)

Qualifications/Requirements

• Degree in Banking / Finance or Accountancy
• 2 - 4 years experience in the financial industry (fund management / insurance business will be preferred) with relevant experience in post-trade compliance platforms, creating and maintaining rules for purposes of portfolio compliance. Knowledge of the various component feeds to the system (fund accounting data base, third party vendor feeds) will be an added advantage.
• Strong working knowledge of investment guidelines, securities ratings and industry classification, benchmark indexes, etc. 
• Demonstrating a high level of accuracy and attention to detail.
• Ability to write macros and rule logic, knowledge of SQL and data mapping will be a plus.
• Computer literate with good working knowledge of Excel & macros. Preferably with working knowledge of SQL and data mapping.
• Able to interpret legal clauses and paraphrase into simple and clear requirements.
• Service-oriented and client focused. A team player with strong oral, written and interpersonal communication skills.
• Willing to work on Singapore public holidays.

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Job Family Group:

Operations - Transaction Services

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Job Family:

Fund Accounting

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Time Type:

Full time

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Citi is an equal opportunity and affirmative action employer.

Qualified applicants will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Citigroup Inc. and its subsidiaries ("Citi”) invite all qualified interested applicants to apply for career opportunities. If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review Accessibility at Citi.

View the "EEO is the Law" poster. View the EEO is the Law Supplement.

View the EEO Policy Statement.

View the Pay Transparency Posting

     

JOB DESCRIPTION:

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Diabetes Care Kilkenny

Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones.  This enables people with diabetes to live the best and fullest lives they can.

At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare. 

This is how you can make a difference at Abbott:

As an Operations Quality Shift Lead, you will be responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process. May supervise inspection and test activities of operators. Performs function failure testing as well as physical defects. This is a shift role on 4 cycles.

Responsibilities

• Oversees operational implementation of quality assurance strategies and regulations.

• Completes the assessment of potential risks, ensures compliance, and gives recommendations to management.

• Supervises team to ensure quality control aspects of the process are met (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services).

• Facilitates audits and regulatory inspections.

• Liaises with external vendors, contractors, or suppliers to ensure that their products or services meet the organisation's quality standards.

• Lead a team of Operations Quality engineers.

• Manage functional area’s compliance to site and divisional policies and procedures.

• Lead the continuous improvement and effective maintenance of the QMS.

• Subject Matter Expert in use of risk management tools to prioritise activities and justify the effort required.

• Accountable for building and maintaining successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals.

• Manage teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance.

• Act as Lead for the monitoring and compliance of the Quality Management System as it applies to site Operations:

• Lead team in making Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging.

• Lead audit readiness in functional area

• Identify and lead projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.

• Champion a “right first time” approach to Quality Records by ensuring accountability for functional responsibilities.

Education and Experience

• A minimum of a NFQ Level 7 Qualification in Science / Engineering or Manufacturing qualification

• Minimum of 4 years’ experience in Manufacturing

• Minimum 2 years’ experience people management

• Yellow belt qualified desired

• Strong communication and organisation skills

• Strong problem solving

• Experience with GMP/GDP

• ISO13485 experience

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as

• Family health insurance,

• Excellent pension scheme

• Life assurance

• Career Development

• Fantastic new facility

• Growing business plus access to many more benefits.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Abbott is an equal opportunities employer.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Anscsl - Shftpre0 - Cfs Flexi 39 Hrs (Ireland)

     

TRAVEL:

Yes, 25 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

Posting End Date:

March 24, 2024

Join John Lewis or Waitrose today

If you've ever stepped through the doors of a John Lewis or Waitrose shop, shopped online, or seen any of our adverts, you'll know there's something unique about us.

That unique proposition is our Partners. As co-owners they have a say in our business and receive a share of the profits, so they put time and effort into making it work. Our Partners are the reason we're the success we are. They're our secret sauce; the opportunity for us to differentiate.

Job Summary:

Job Description:

#LI-JLPWTR          

#LI-JLPGR             

#LI-JLPJL             

#LI-AB1

Pay Range:

£24,800.00 up to £37,300.00 Annual

Scheduled Weekly hours:

37.5

Worker Type:

Permanent Partner

Job Level:

Partnership Level 9

Hours of Work:

Shift pattern: 06:00 - 14:00, 14:00 - 22:00

At the John Lewis Partnership, we embrace our differences. We want you to be you. Because, well, we know you're at your best when you're free to be yourself.

Being a truly inclusive employer to us means creating an environment which celebrates your contribution, regardless of age, gender, race, ethnicity, disability, sexual orientation, social background, religion or belief. It's why we've set our own aim to become the UK’s most inclusive business - for our Partners (employees) and our customers.

We firmly believe that our future success lies in diversity of thought from all Partners and it's integral in our mission to build a happier world. 🌍 💚

We welcome applications from everyone interested in working for us. And, once you're a Partner, your differences will make all the difference.

Find out more about D&I in the Partnership here.

We want all of our Partners to have a good work-life balance and we support flexible working. This might mean flexible or compressed hours, job sharing or shorter hour contracts, where it is possible to do so. Please discuss this further with the hiring manager during your interview.

-

     

JOB DESCRIPTION:

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Diabetes Care Kilkenny

Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.

At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare. 

This is how you can make a difference at Abbott:

As a Quality Compliance Lead you will be responsible for leading a Process or leading a team of Quality professionals. Management of applicable Quality System requirements within the QA functional area, in accordance with corporate, divisional and applicable regulatory requirements.

Key Responsibilities

• Implement a work environment that ensures all communication, interpersonal interactions and business activities are consistent with ADC values and the Abbott Code of Conduct.

• Maintain an appropriate balance of quality, compliance, and business risk. Provide compliant yet practical solutions that minimise the impact of Quality issues.

• Represent ADC to internal/external Auditors and Regulatory bodies on any issue related to the area of responsibility.

• Ensure the area of responsibility and processes are audited at all times, and all audits are supported from a resource and information request perspective.

• Manage the investigation of non-conformances affecting the area of responsibility and ensure timely and effective corrective action.

• Present and inform the status, report metrics, identify trends and potential issues.

• Escalate to management any issues pertaining to non-compliance or failure to achieve agree performance targets.

• Maintain the quality and compliance of related procedures, work instructions and training materials.

• Identify and implement initiatives to enhance the Quality System.

• Provide effective communication with other staff and Quality Management to share information and support the attainment of ADC Quality and business objectives.

• Ensure quality and compliance within the business and across the Division.

• Consult with the QA Management regarding the recruitment of staff, ensuring that staffing levels are maintained, and recruitment activities are scheduled in accordance with departmental requirements.

• When requested, accept any responsibilities, and perform any necessary tasks to support the business and other QAC activities.

• Maintain a consistent approach to Health and Safety issues within the working environment to reduce hazards and risk.

• Prioritize and coordinate resources to ensure department and site objectives are achieved.

• Provide divisional level support and guidance as SME for area of responsibility.

• Provide effective guidance and build and maintain effective cross functional relationships with all areas of the business.

Qualifications and Experience

• Minimum Level NFQ Level 7 Qualification or equivalent experience.

• Minimum of 4 years’ experience in a similar position.

• Prior experience of development and/or manufacture of regulated products to ensure familiarity with GMP and/or ISO Quality Systems.

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as

• Family health insurance,

• Excellent pension scheme

• Life assurance

• Career Development

• Fantastic new facility

• Growing business plus access to many more benefits.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Abbott is an equal opportunities employer.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Shftpre0 (Ireland)

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

     

JOB DESCRIPTION:

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 113,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries.

Job Description:

Responsible for implementing and maintaining the effectiveness of the Design Controls systems across IDEM Manufacturing plants

Responsibilities and Duties:

• Develop and execute strategies to optimize Design Controls process within IDEM and ensure   compliance and connectivity to the broader Abbott design assurance process requirements.

• Provide design assurance oversight to all functions operating in the New Product Introduction area.

• Define clear roles and responsibilities for all functions to ensure effective execution of the design controls process (R&D, RA, PM, Operations, Clinical).

• Ensure timely communication with VP of QA and Senior Leaders on critical design quality

• Manage resources to support product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes.

• Conduct/Coordinate regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects.

• Ensure that product/process/package/label/Test Method designs and associated documentation comply with applicable Regulations for products distributed globally (US/OUS).

• Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed loop feedback system to the design process.

• Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.

• Design Controls SME and person directly responsible to represent IDEM with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality.

• Participate in Regulatory Agency inspections and respond to queries related to product design controls, change control and complaints.

• Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission.

• Establish and execute design control policies, procedures, processes and principles to ensure robust product designs, appropriate evaluation during development and document change controls compliant with requirements.

• Collaborate with R&D in the development of Design test protocols and study plans and ensure both test plans and reports are compliant with all applicable regulatory requirements.

• Work with R&D to ensure that Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately.

• Work with R&D to ensure successful and cost-effective product scale-up and technology transfer from R&D to commercial manufacture.

• Establish a post launch review process that monitors new product performance against the expected market performance and triggers escalation/intervention as necessary.

• Develop design assurance processes, systems, and Staff, delivering a high performing team that supports successful NPI execution across all IDEM Sites.

Requirements:

• Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment.

• Proven track record of results managing projects in a highly regulated environment.

• Strong Leadership capability and ability to influence change balancing compliance with pragmatic

• Problem solving.

• Proven track record in delivering successful NPI programs on budget and on time.

• Proven track record in delivering Continuous Improvement programs.

• Must have strong technical ability and be articulate in message delivery.

• Ability to work and interact with several cultures across various time zones.

• Excellent written and verbal interpersonal skills to influence many diverse internal and external stakeholders.

• Ability to present complex technical information to Senior Management.

Education & Experience:

• Bachelor’s Degree – Engineering/Science/Life Sciences - Post graduate degree desirable.

• 5 years plus experience in a QA/R&D 0r other technical leadership role in a regulated environment.

• Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainty.

• Experience managing a design assurance team is essential and preferably experience working with teams remotely.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

     

JOB DESCRIPTION:

About Abbott

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 113,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries

Job Description Summary:

This Quality Professional position is focused on supporting the establishment of ARDx ID Galway as a legal manufacturer entity for select on-market and new products. Additionally, this role is focused on supporting the implementation & maintenance of ADRx’s Quality System in alignment with applicable regulations and standards including ISO 13485, FDA 21 CFR 820 etc. The Quality Professional leads activities assigned to them, collating needed inputs and working collaboratively with a broad cross-functional team.

Main Responsibilities:

• Provide support to the implementation of the applicable quality system at ARDx ID Galway.
• Provide compliance oversight and guidance for design transfer activities for both entity & IVDR transfers and NPI, as assigned.
• Maintain awareness of applicable quality standards that regulate our industry. Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Support and/or lead the review and approval of quality system procedures and design records.
• Support and/or lead the development and update of associated Risk Management files.
• Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
• Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.
• Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
• Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.

Scope:

• Receives general direction and exercises considerable discretion to work own detail. Recommends possible solutions.
• Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.

Education: Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

Experience:

• At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.
• Preferred experience in the Healthcare industry.
• Has a history of completing successful projects and driving positive compliance outcomes.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

     

JOB DESCRIPTION:

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 113,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries

Job Description Summary:

This Quality Professional position is focused on supporting the implementation & maintenance of ADRx’s post-market surveillance reporting to meet the requirements for the In-Vitro Diagnostics Regulation (IVDR) into ARDx’s Quality System. Additionally, the Principal Quality Professional for post-market surveillance reporting leads activities assigned to them, collating needed inputs for reporting, working collaboratively with a broad cross-functional team.

Main Responsibilities:

• Supports the implementation and maintenance of the effectiveness of the Quality System with respect to collation of data and generation of reports required to support post market surveillance reporting submissions, as assigned.
• Works collaboratively with a global cross-functional team to revise existing or establish new quality system requirements/processes, procedures and report templates compliant with the new regulation with respect to post-market surveillance reporting.
• Uses critical thinking to provide solutions that are compliant, innovative and consistent with organizational objectives.
• Coordinates and leads the assigned schedule associated with the accrual, assembly of post-market surveillance inputs ensuring accurate and timely submission. Supports the processes for acquiring, managing, analyzing, interpreting and reporting Post Market Surveillance data necessary to support PMS Reports such as Periodic Safety Update Report (PSUR), Post Market Performance Follow-Up (PMPF), Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents such as Risk Management Files (RMF).
• Partners with Vigilance, Regulatory Affairs, Clinical Affairs, product, instrument and software teams, Field Assurance, Marketing and manufacturing facilities to proactively plan for and complete PMS reports, ensuring needed data is gathered accordingly.
• Elevates and articulates concerns to management in a timely manner, proposing solutions and leading change as needed.
• As a post-market surveillance reporting subject matter experts, supports audits and additional information request inquiries relating to post-market surveillance reporting.

Scope:

• Receives general direction and exercises considerable discretion to work own detail. Recommends possible solutions.
• Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.
   

Education:

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

Experience:

• At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.
• Preferred experience in the Healthcare industry.
• Has a history of completing successful projects and driving positive compliance outcomes.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

     

JOB DESCRIPTION:

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Shftpre0 (Ireland)

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

     

JOB DESCRIPTION:

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Shftpre0 (Ireland)

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable