Senior Quality Engineer
Listed on 2026-07-03
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Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
We are the people who give possibilities purpose
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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job DescriptionReporting directly to the Associate Director of Quality, you’ll be at the heart of our product development journey, applying your Quality Engineering expertise to both cutting-edge new products and essential product maintenance initiatives. This is your opportunity to make a real impact on patient safety and product excellence throughout the entire product lifecycle.
ResponsibilitiesDrive Quality Excellence: Apply advanced technical principles, quality sciences, and proven methodologies to ensure our medical devices exceed industry standards and regulatory expectations
Solve Complex Challenges: Leverage your proven problem-solving skills to tackle quality issues head-on, creating measurable improvements to BD’s processes and procedures that enhance efficiency and effectiveness
Champion Regulatory Compliance: Ensure every design control and production/process control project meets all applicable local and international regulatory requirements, plus Corporate and Unit standards
Collaborate Cross-Functionally: Serve as the Quality representative on dynamic new product development and sustaining engineering teams, bringing your expertise to multidisciplinary projects
Exercise Approval Authority: Review and provide Quality Engineering approval for new and modified design/process specifications, including product performance specs, test methods, and critical documentation
Develop Auditing
Skills:
Participate in supplier and internal quality system audits as an Auditor-in-training, evaluating the effectiveness of our Quality System and good manufacturing practicesLead Project Quality: Ensure quality conduct across projects—from design through data interpretation and report generation—for both your work and that of junior team members
Shape Our Future: Contribute to specific programs and projects that advance our quality capabilities, and prepare/revise policies and procedures that guide our organization
Own the Journey: Manage projects and tasks from product inception through launch and ongoing maintenance, ensuring products consistently meet quality standards at every stage
- Bachelor’s degree in Engineering and 5 years relevant experience OR
- Master’s degree in Engineering and 3 years relevant experience.
Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
Can independently determine and develop approach to solutions.
Able to provide guidance and work direction to lower level project developers.
Can design and perform development working independently within defined parameters with minimal supervision required.
Experience with BD software systems utilized in the Quality Systems is desirable.
Must have knowledge/specialization in one or more of the following areas:
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential 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.
At BD, we are committed to supporting our associates’ well‑being, development,…
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