Job Description Summary
A results-driven Quality Engineer with expertise in risk management, process validation (IQ, OQ, PQ), test method development, and quality system improvements. Skilled in conducting root cause investigations, supplier qualifications, and regulatory compliance to ensure seamless operations. Adept at collaborating with cross-functional teams, supporting audits, and driving continuous improvement through data-driven decision-making. Committed to maintaining the highest industry standards and enhancing quality processes for operational excellence.
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.
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Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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.
Become a maker of possible with us!
Our vision for Peripheral Intervention at BD
Our Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.
About the role
The Quality Engineer will work ensuring compliance, driving process improvements, and maintaining the highest industry standards collaborating with cross-functional teams to represent quality interests and facilitate seamless project and process transfers into production, proficient in drafting, reviewing, and updating risk management documentation (pFMEA), test method validation protocols, and process validation reports (IQ, OQ, PQ) to uphold product integrity and regulatory compliance. Experienced in developing inspection procedures, test methods, and statistically valid sampling plans to optimize quality control.
Will conduct root cause investigations, data verification, and gap analysis, identifying opportunities for continuous improvement, and implementing quality system enhancements through change management. This role requires expertise in supplier qualification, internal and external audits, and regulatory compliance alignment to maintain seamless operations.
A proactive problem-solver with a meticulous approach to monitoring and managing quality metrics, supporting internal, corporate, customer, and notified body audits, and ensuring adherence to global and corporate quality management standards, policies, and regulations and committed to excellence in quality assurance, risk mitigation, and operational efficiency would be the perfect candidate.
Main responsibilities will include:
- Represent quality interests and concerns in conjunction with a cross functional team.
- Provide support for project/process transfer to production.
- Lead Quality Engineering activities as part of a cross functional team.
- Drafting, reviewing and updating risk management documentation, as required e.g. pFMEA
- Drafting and execution of Test Method Validation Protocols and Reports.
- Develop or assist in the development of inspection procedures and test methods for Receiving Inspection, In Process inspections or Final Release Testing.
- Determination of appropriate sampling plans based upon valid statistical rationales and historical data.
- Review of Process Validation Documentation (e.g. IQ, OQ, PQ).
- Completion of Data Verification activities.
- Support qualification activities for new suppliers and new component qualification, as required.
- Identification of quality system improvement opportunities and execution through the change management system.
- Completion of root cause investigations for nonconformances, as required.
- Completion of Gap Analysis activities.
- Responsible for compilation and communication of data for Management Review, as required.
- Provide support for audits including internal, corporate, customer and notified body audits.
- Participate in internal audit or supplier audit programs, as required.
- Ensure alignment of the quality system with changes in global and corporate quality management standards, polices or regulations.
- Management and monitoring of Quality Metrics, as required.
About you
- Third level Engineering/Technical/Science Qualification.
- Min 3 years' experience in the medical device or pharmaceutical industry.
PreferredKnowledgeandSkills
- Working knowledge of ISO 13485 and its applicability to the manufacturing environment.
- Experience with risk management, particularly pFMEA and familiarity with ISO 14971.
- Experienced in use of statistical software packages e.g. MiniTab
- Experience in the execution of all stages of Gage R&R / Test Method Validation.
- Experience in auditing (internal and / or supplier), Lead Auditor Qualification is advantageous.
- Working knowledge of change control processes, non-conformance & CAPA.
- Working knowledge of cGMP and cleanroom requirements.
Click on apply if this sounds like you!
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are crucial in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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.
To learn more about BD visit: https://bd.com/careers
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Primary Work Location
IRL Wexford - Enniscorthy
Additional Locations
Work Shift