Lead Quality Engineer - Medical Device Combos

Biopharma Careers; Foster City (CA); On-site; USD 158,000 - 204,000; Full time

Benefits offered by this job

Medical, dental, vision, and life-ins

Paid time off

Discretionary stock-based incentives

Job summary

Gilead Sciences Inc. in Foster City, CA, is seeking a Lead Quality Engineer for medical device combination product development. You will drive design controls, risk management, and lifecycle quality oversight across programs.

Collaborate with Device Engineering to support design verification, design validation, and technology transfer activities while ensuring regulatory compliance with FDA/ISO standards. This role involves coordinating with internal teams and CMOs, leading quality improvements,

Qualifications

• 8+ years of QA experience for medical devices and/or drug-device combination products.
• Experience with design controls and risk management.
• Excellent written and verbal communication across functions.

Responsibilities

• Lead Quality Engineer for medical device combination product development with focus on design controls, risk management and lifecycle quality oversight.
• Partner with Device Engineering on design verification, design validation and technology transfer activities.
• Ensure compliance with regulatory requirements and standards (FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 and GQS).
• Plan, implement and track approved quality improvement initiatives and action items.
• Interface with cross-functional teams, CMOs and suppliers to resolve complex quality issues related to drug-device combinations.

Skills

Quality Assurance

Medical devices

FDA regulations

Design controls

Risk management

Communication skills

Cross-functional collaboration

Change controls

Education

Bachelor's degree in Engineering or scientific discipline

Master's degree in related field

Tools

Regulatory knowledge

Job description

Gilead Sciences Inc. in Foster City, CA, is seeking a Lead Quality Engineer for medical device combination product development. You will drive design controls, risk management, and lifecycle quality oversight across programs.

Collaborate with Device Engineering to support design verification, design validation, and technology transfer activities while ensuring regulatory compliance with FDA/ISO standards. This role involves coordinating with internal teams and CMOs, leading quality improvements,