Quality Engineer III

Gilead Sciences • Foster City, CA

8d

About The Position

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 projects, with a strong emphasis on design control and risk management activities. Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities. Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead’s quality system requirements. Plan and implement approved quality improvement action items and deliverables. Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products,processes, and quality. Act as an escalation point for complex and high-impact quality issues, concerns, and decisions. Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs). Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. Develop and/or review controlled documents (e.g., protocols, reports, plans, risk analyses, specifications, test methods).

Requirements

• Bachelor's degree in engineering or a scientific discipline with at least 5 years of relevant experience, OR a Master's degree in a relevant field with at least 3 years of relevant experience.
• Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
• Excellent verbal, written, and interpersonal communication skills

Nice To Haves

• Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred.
• Strong project management and process improvement skills.
• Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
• Possess a strong foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, GageR&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these areas is required
• Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
• Strong knowledge of medical devices and or combination products manufacturing.

Responsibilities

• Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities.
• Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities.
• Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead’s quality system requirements.
• Plan and implement approved quality improvement action items and deliverables.
• Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products,processes, and quality.
• Act as an escalation point for complex and high-impact quality issues, concerns, and decisions.
• Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs).
• Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments.
• Develop and/or review controlled documents (e.g., protocols, reports, plans, risk analyses, specifications, test methods).

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level