Senior Quality Engineer- Combination Product Development

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
 

Responsibilities:

• Serve as a 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 Part 4, 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).

Qualifications:

• Bachelor's degree in engineering or a scientific discipline with at least 6 years of relevant experience, OR a Master's degree in a relevant field with at least 4 years of relevant experience.
• Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
• 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.
• Knowledge of basic statistical techniques (e.g., normality tests, capability analysis, tolerance intervals) is preferred.
• Experience with test method validation (MSA, Gage R&R) is preferred.
• Experience with risk management principles according to ISO 14971, including the use of risk management tools such as FMEA and systems analysis, is highly desirable.
• 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.
• Excellent verbal, written, and interpersonal communication skills.

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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