Lead Quality Engineer - Medical Device Combinations

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

Job summary

Gilead is seeking a Lead Quality Engineer to drive quality for medical device combination product development programs. You will lead design controls, risk assessment, and lifecycle quality oversight, partnering with Device Engineering to support verification, validation, and technology transfer.

The role requires strong QA experience with medical devices or drug-device combos, excellent communication, and ability to influence across functions in a regulated environment.

Qualifications

• Bachelor’s degree in Engineering or a scientific discipline with at least 6 years of relevant experience.
• Master’s degree in a related field with at least 4 years of relevant experience.
• Demonstrated experience in Quality Assurance for medical devices and/or drug‑device combination products.
• Excellent verbal, written, and interpersonal communication skills.
• At least 8 years of experience supporting combination products with design controls and risk management.
• Strong project management and process improvement capabilities.
• Working knowledge of domestic and international quality system regulations and ability to drive continuous improvement.
• Strong foundation in statistical methods including MSA and Gage R&R.
• Advanced proficiency in risk management per ISO 14971 including FMEA and hazard analysis.
• Ability to develop and evolve complex quality concepts and methodologies.

Responsibilities

• Lead Quality Engineer for medical device combination product development programs with focus on design controls and lifecycle quality oversight.
• Partner with Device Engineering on design verification, design validation, and technology transfer activities.
• Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 and Gilead Quality System requirements.
• Plan, implement, and track quality improvement initiatives and action items.
• Interface with internal teams, CMOs, and suppliers to resolve complex quality issues on drug-device products.
• Act as escalation point for high-impact quality issues, risks, and decisions.
• Provide quality guidance and impact assessments for change controls and DHF/RMF evaluations.
• Develop, review, and approve controlled documentation including protocols and test methods.

Skills

Quality Assurance

Regulatory affairs

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Engineering or science

Master’s degree in related field

Job description

Gilead is seeking a Lead Quality Engineer to drive quality for medical device combination product development programs. You will lead design controls, risk assessment, and lifecycle quality oversight, partnering with Device Engineering to support verification, validation, and technology transfer.

The role requires strong QA experience with medical devices or drug-device combos, excellent communication, and ability to influence across functions in a regulated environment.