Senior Quality Engineer

Bio Talent is hiring a Senior Quality Engineer for a medical device company in San Diego to own and continuously improve their Quality Management System across the full product lifecycle.

This is a hands-on, high-ownership role reporting directly to the VP.

• Coordinate and maintain QMS processes and documentation across the organization
• Lead the design control program in partnership with R&D, clinical, and operations
• Represent Quality within the change control system — reviewing and approving changes
• Lead CAPA activities including root cause analysis, problem definition, and effectiveness checks
• Support NMR and complaint handling, supplier qualification, and incoming inspection
• Lead the internal audit program and support external audit and inspection readiness

• B.S. in a technical discipline
• 4-5 years in a quality role within a medical device manufacturing environment
• 3+ years of quality system auditing experience
• Strong command of ISO quality systems and harmonized standards for medical devices

Nice to have:
Software-enabled/connected device experience, FDA inspection support, MDR/CE marking, diabetes clinical space background