Sr. Quality Engineer

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.

• Quality Leadership Across the Product Lifecycle:
  Serve as the Quality Assurance expert for your entire product line, owning Design Control, Document Control, and QA processes from concept to commercialization.
• Strategic Partnership:
  Collaborate with contract manufacturers and internal plants to seamlessly implement changes while maintaining the highest quality standards.
• Proactive
  
  Risk Management:
  
  Monitor complaint trends, identifying performance drift before it becomes a problem and executing swift corrective actions.
• Subject Matter Authority:
  Be the go-to resource for cross-functional teams in Engineering, Operations, and supplier management.
• Champion Design Control Excellence:
  Serve as the Quality Representative on Project Teams, ensuring Design Control principles are woven into every Product and Process Change and New Product Development initiative.
• Lead Quality Initiatives:
  Provide QA leadership for Project Teams and the Quality Department.
• Master Documentation:
  Build, review, and approve critical Quality System Documents including CAPAs and Audit reports.
• Craft Compliance Artifacts:
  Create and approve Design History Files, ensuring every product decision is documented and defensible.
• Validate Everything:
  Develop, review, and approve Protocols for Process and Product Validations, Stability studies, and Software Validation documents.
• Assess and Mitigate Risk:
  Create comprehensive Risk Assessments using FMEA, FMECA, and FTA methodologies.
• Develop Talent:
  Mentor staff and provide supervision to technicians and engineers, building the next generation of quality professionals.
• Drive Continuous Improvement:
  Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.
• Audit with Authority:
  Conduct Internal and Supplier Quality System Audits to ensure compliance across the supply chain.
• Stay Ahead of the Curve:
  Maintain active membership in trade and professional organizations, bringing state‑of‑the‑art industry standards back to the team.
• Investigate and Resolve:
  Perform thorough Complaint reviews and investigations, getting to the root cause quickly.
• Track Success Metrics:
  Monitor and trend Quality Indicators to demonstrate continuous improvement.
• Collaborate Across Sites:
  Work seamlessly with manufacturing facilities and other Division Facilities to ensure quality consistency.
• Chair Critical Reviews:
  Serve as Independent QA Reviewer and Chairperson for Design Reviews, making the tough calls when needed.

• Bachelor's Degree in Engineering and 4 Years of Quality Engineering experience in a regulated environment OR Master's Degree and 2 Years of Quality Engineering experience in a regulated environment.

• Good questioning and problem‑solving skills.
• Detail-oriented and ability to organize large amounts of work and data, including good documentation practices and effective team planning.
• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA.
• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability.
• Demonstrated history of successfully interpreting regulations and procedures.
• Demonstrated skill in statistical analysis and applied statistical methodologies.
• Knowledge and understanding of IEC
  60601 standards.

• Capital system experience (Electro‑mechanical).
• ASQ Certification.

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…