Sr. Quality Engineer I- Combination Products

Regulatory Toolkit; Foster City (CA); Sur place; USD 136 000 - 176 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

Regulatory affairs

Cross-functional collaboration

Communication skills

Formation

Bachelor’s degree in Engineering or science

Master’s degree in related field

Description du poste

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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 6 years of relevant experience, OR
• 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, with the ability to influence across functions.

Preferred Qualifications

• At least 8 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: $136,340.00 - $176,440.00. 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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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] for assistance.

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