Staff Quality Assurance Engineer

BioTalent; San Diego (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

BioTalent is hiring a Staff 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. Responsibilities include leading QMS processes, design control, change control reviews, CAPA, complaints handling, supplier qualification, audits, and readiness for external inspections.

Qualifications

• BS in a technical discipline.
• 8–10+ 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.

Responsibilities

• 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.

Education

B.S. in a technical discipline

Job description

BioTalent is hiring a Staff 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.

Responsibilities:

• 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

Requirements:

• B.S. in a technical discipline
• 8-10+ 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