Senior Quality Engineer

BioTalent; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent in San Diego is seeking a Senior Quality Engineer to own and continuously improve the Quality Management System across the full product lifecycle for a medical device company. This is a hands-on, high-ownership role reporting directly to the VP.

This position requires collaboration with R&D, clinical, and operations to ensure quality across design, development, and manufacturing activities and to support regulatory readiness.

Qualifications

• B.S. in a technical discipline required.
• 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.

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.

Skills

Quality engineering

Auditing

Problem solving

Cross-functional collaboration

Education

B.S. in a technical discipline

Tools

Quality management software

Job description

BioTalent 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.

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
• 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