Quality Engineering Supervisor/Manager

BioTalent; San Diego (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BioTalent in San Diego is seeking a Quality Engineering Supervisor/Manager to lead and continuously improve the Quality Management System across the full product lifecycle. This hands-on, high-ownership role includes people leadership reporting directly to a VP, with responsibilities spanning QMS, design controls, CAPA, change control, and audits.

The ideal candidate has 5+ years in medical device quality, strong ISO knowledge, and prior supervisory experience, with hands-on execution能力 to

Qualifications

• BS in a technical discipline.
• 5-7+ years quality experience in medical device manufacturing with leadership.
• 3+ years of quality system auditing experience.
• Prior supervisory or managerial experience required.
• Strong command of ISO quality systems and harmonized standards for medical devices.

Responsibilities

• Lead and mentor a small team of Quality professionals, providing technical direction and performance guidance.
• 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.
• Oversee NMR and complaint handling, supplier qualification, and incoming inspection.
• Lead the internal audit program and support external audit and inspection readiness.

Skills

Team leadership

Quality systems

Root cause analysis

Auditing

Education

B.S. in a technical discipline

Job description

BioTalent is hiring a Quality Engineering Supervisor/Manager for a medical device company in San Diego to lead and continuously improve their Quality Management System across the full product lifecycle. This is a hands-on, high-ownership role with people leadership responsibility, reporting directly to a VP.

Responsibilities:

• Lead and mentor a small team of Quality professionals, providing technical direction and performance guidance
• 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
• Oversee 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
• 5-7+ years in a quality role within a medical device manufacturing environment, including prior team leadership or supervisory experience
• 3+ years of quality system auditing experience
• Prior Supervisory or Managerial experience is required
• Strong command of ISO quality systems and harmonized standards for medical devices
• Hands-on execution experience with proven ability to lead and develop a team

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