Sr Quality Engineer II - Combination Products

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

Job summary

Regulatory Jobs is seeking a Lead Quality Engineer to drive quality for medical device combination product development in a fast-paced environment. You will lead design controls, risk management, and lifecycle quality oversight across programs and collaborate with Device Engineering on verification, validation, and tech transfer.

The role emphasizes regulatory compliance to FDA/ISO standards, with ongoing quality improvements, cross-functional communication, and key involvement with CMOs and

Qualifications

• Bachelor’s degree in Engineering or a scientific discipline with at least 8 years of relevant experience, OR Master’s degree with at least 6 years.
• Demonstrated experience in Quality Assurance for medical devices and/or drug-device combination products.
• Excellent verbal, written, and interpersonal communication skills, with the ability to influence across functions.
• Preferred: 10+ years supporting combination products with deep expertise in design controls and risk management.

Responsibilities

• Serve as a Lead Quality Engineer for medical device combination product development programs with a focus on design controls, risk management, and lifecycle quality oversight.
• Partner with Device Engineering on new development, supporting design verification, design validation, and technology transfer.
• Ensure compliance with regulatory standards including FDA 21 CFR Part 820, ISO 13485, ISO 14971 and related quality systems.
• Plan, implement, and track quality improvement initiatives with timely action on deliverables.
• Interface with cross-functional teams, CMOs, and suppliers to resolve complex quality issues for drug-device combinations.
• Act as escalation point for high-impact quality issues, risks, and decisions.
• Support strategic relationships with internal stakeholders and CMOs.
• Provide quality guidance for change controls, DHF, and RMF evaluations.
• Develop, review, and approve controlled documentation such as protocols, plans, reports, and risk analyses.

Skills

Lead Quality Engineer

Medical device development

Design controls

Risk management

Lifecycle quality

FDA compliance

Quality system

Design verification

Education

Bachelor’s degree in Engineering or a scientific discipline

Master’s degree in a related field

Tools

MSA

Gage R&R

FMEA

ISO 14971

Job description

Job Description

Key Responsibilities

• Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight.
• Partner closely with Device Engineering on new combination product development, supporting design verification, design validation, and technology transfer activities.
• Ensure compliance with applicable regulatory requirements and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.
• Plan, implement, and track approved quality improvement initiatives, ensuring timely execution of action items and deliverables.
• Interface with internal cross‑functional teams, contract manufacturers, and suppliers to resolve complex technical and quality issues related to drug‑device combination products, processes, and manufacturing.
• Act as an escalation point for complex, high‑impact quality issues, risks, and decisions.
• Support and strengthen strategic relationships with internal stakeholders and Contract Manufacturing Organizations (CMOs).
• Provide quality guidance and impact assessments for change controls, including evaluations of Design History Files (DHF) and Risk Management Files (RMF).
• Develop, review, and approve controlled documentation, including protocols, plans, reports, risk analyses, specifications, and test methods.

Basic Qualifications

• Bachelor’s degree in Engineering or a scientific discipline with at least 8 years of relevant experience, OR
• Master’s degree in a related field with at least 6 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, with the ability to influence across functions.

Preferred Qualifications

• At least 10 years of experience supporting combination products (e.g., autoinjectors, pre‑filled syringes, co‑packaged kits), with deep expertise in design controls and risk management.
• Strong project management and process improvement capabilities.
• Working knowledge of domestic and international quality system regulations and the ability to drive continuous improvement in regulated environments.
• Strong foundation in statistical methods, including normality testing, capability analysis, tolerance intervals, and test method validation (MSA, Gage R&R).
• Advanced proficiency in risk management per ISO 14971, including FMEA, system‑level risk analysis, and hazard analysis (expertise in at least one area required).
• Ability to develop and evolve complex quality concepts, standards, and methodologies based on sound quality engineering principles.
• Strong knowledge of medical device and/or combination product manufacturing operations.

The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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