Lead Quality Engineer — Medical Device Combos

Biopharma Careers; Foster City (CA); On-site; USD 136,000 - 176,000; Full time

Job summary

Gilead Sciences Inc. seeks a Lead Quality Engineer for medical device combination products, stressing design controls, risk management, and lifecycle quality oversight.

You will collaborate with Device Engineering on verification, validation, and tech transfer, ensuring compliance with FDA 21 CFR Part 820, ISO 13485/14971 and the Gilead Quality System. Responsibilities include leading improvement initiatives, resolving complex issues with cross-functional teams, CMOs, and suppliers, and guiding

Qualifications

• Bachelor’s degree in Engineering or a scientific field with relevant experience, or a related Master’s degree.
• Demonstrated experience in Quality Assurance for medical devices or drug–device products.
• Excellent verbal, written, and interpersonal communication across functions.

Responsibilities

• Serve as Lead Quality Engineer for medical device combination product programs with design controls focus.
• Collaborate with Device Engineering on DVC verification, validation, and tech transfer.
• Ensure compliance with FDA/ISO quality regs and internal Gilead requirements.
• Plan, implement and track quality improvement initiatives and action items.
• Interface with cross-functional teams, CMOs, and suppliers to resolve issues.

Skills

Quality Engineer

Design controls

Risk management

Regulatory knowledge

Quality systems

Communication skills

Education

Bachelor’s degree in Engineering or scientific discipline

Master’s degree in related field

Tools

MSA

Gage R&R

FMEA

Job description

Gilead Sciences Inc. seeks a Lead Quality Engineer for medical device combination products, stressing design controls, risk management, and lifecycle quality oversight.

You will collaborate with Device Engineering on verification, validation, and tech transfer, ensuring compliance with FDA 21 CFR Part 820, ISO 13485/14971 and the Gilead Quality System. Responsibilities include leading improvement initiatives, resolving complex issues with cross-functional teams, CMOs, and suppliers, and guiding