Senior Supplier Quality Engineer – NPD & Compliance

Regulatory Jobs; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD is a global medical technology leader focused on advancing health. We seek a senior professional to lead supplier qualification, audits, and quality initiatives supporting NPD and product lifecycle programs.

You will define qualification strategies, drive CAPA programs, and collaborate with BD sites to optimize inspection and supplier relations, while mentoring junior engineers in quality engineering practices.

Qualifications

• Bachelor’s degree in engineering or scientific field and 6 years’ experience (industry or industry/education)
• Master's degree or equivalent in Engineering or Scientific field with 5 years’ experience (industry or industry/education)
• Ph.D. or equivalent in Engineering or Scientific field with 2 years’ experience (industry or industry/education)

Responsibilities

• Lead qualification, supplier auditing, and qualification for NPD projects.
• Define qualification strategies for components, devices, and materials.
• Improve supplier sites with quality systems and process controls.
• Develop, validate, and implement inspection/test methods for quality and regulatory compliance.
• Lead investigations for field issues, root cause, and CAPAs.
• Collaborate with BD sites to optimize receiving inspection strategies.
• Drive Lean/Six Sigma initiatives for DFM and operational excellence.
• Manage supplier relationships through assessments and forums.
• Mentor engineers in advanced quality engineering practices and supplier processes.

Skills

FDA regulations

ISO 13485

ISO 14971

Supplier controls

CAPA management

Six Sigma

Risk management

Gage R&R

DOE

Education

Bachelor’s degree in engineering or Scientific field

Master's degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Job description

BD is a global medical technology leader focused on advancing health. We seek a senior professional to lead supplier qualification, audits, and quality initiatives supporting NPD and product lifecycle programs.

You will define qualification strategies, drive CAPA programs, and collaborate with BD sites to optimize inspection and supplier relations, while mentoring junior engineers in quality engineering practices.