Senior Quality Assurance Engineer (Medical Device)

Meet Life Sciences Ltd.; San Jose (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. in San Jose, CA is seeking a Senior Quality Assurance Engineer to lead and own the QMS for its medical device products.

You will serve as the primary quality representative across the organization and drive CAPA, audits, and continuous improvement initiatives. You will own the QMS and support design controls, risk management, V&V, and process validation, while ensuring compliance with FDA and ISO 13485 standards.

Qualifications

• 8+ years of medical device quality experience.
• Hands-on QMS ownership for commercial devices.
• Experience hosting FDA inspections and ISO 13485 audits.
• Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, MDR, and CAPA.
• Experience with design controls, supplier quality, complaint handling, and processes.

Responsibilities

• Own and maintain the QMS in compliance with FDA and ISO 13485 requirements.
• Lead FDA inspections, external audits, and internal audit programs.
• Manage CAPA, complaints, nonconformances, supplier quality, and document control.
• Support design controls, risk management, V&V, and process validation activities.
• Drive quality metrics, management reviews, and continuous improvement initiatives.

Skills

QMS ownership

Audit management

CAPA handling

Design controls

Regulatory compliance

V&V

Process validation

Risk management

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Senior Quality Assurance Engineer (Medical Device)

A growing commercial-stage medical device company is seeking a Senior Quality Assurance Engineer to lead and own its Quality Management System (QMS) and serve as the primary quality representative across the organization.

What You\'ll Do

• Own and maintain the QMS in compliance with FDA and ISO 13485 requirements
• Lead FDA inspections, external audits, and internal audit programs
• Manage CAPA, complaints, nonconformances, supplier quality, and document control
• Support design controls, risk management, V&V, and process validation activities
• Drive quality metrics, management reviews, and continuous improvement initiatives

What We\'re Looking For

• Bachelor\'s degree in Engineering, Life Sciences, or related field
• 8+ years of medical device quality experience
• Hands-on ownership of QMS for commercial medical devices
• Experience hosting FDA inspections and ISO 13485 audits
• Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, MDR, and CAPA processes
• Experience with design controls, supplier quality, complaint handling, and process validation

Nice to Have

• Catheter-based, imaging, or optical medical device experience
• 510(k) submission support
• Startup environment experience
• eQMS administration or implementation

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