Sr Quality Engineer II - Combination Products

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 aLead Quality Engineer formedical device combination product developmentprograms, with a strong focus ondesign controls, risk management, and lifecycle quality oversight.

• Partner closely withDevice Engineering on new combination product development, supportingdesign verification, design validation, and technology transferactivities.

• Ensure compliance with applicableregulatory requirements and standards, includingFDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.

• Plan, implement, and track approvedquality improvement initiatives, ensuring timely execution of action items and deliverables.

• Interface withinternal cross‑functional teams, contract manufacturers, and suppliers to resolve complex technical and quality issues related todrug‑device combination products, processes, and manufacturing.

• Act as anescalation point for complex, high‑impact quality issues, risks, and decisions.
• Support and strengthenstrategic relationships with internal stakeholders and Contract Manufacturing Organizations (CMOs).

• Providequality guidance and impact assessments for change controls, including evaluations ofDesign History Files (DHF) andRisk Management Files (RMF).

• Develop, review, and approvecontrolled documentation, including protocols, plans, reports, risk analyses, specifications, and test methods.

Basic Qualifications

•Bachelor’s degree in Engineering or a scientific discipline with at least8 years of relevant experience,OR

•Master’s degree in a related field with at least6 years of relevant experience.

• Demonstrated experience inQuality Assurance for medical devices and/or drug‑device combination products.

• Excellentverbal, written, and interpersonal communication skills, with the ability to influence across functions.

Preferred Qualifications

•At least 10 years of experience supportingcombination products (e.g., autoinjectors, pre‑filled syringes, co‑packaged kits), with deep expertise in design controls and risk management.

• Strongproject management andprocess improvementcapabilities.

• Working knowledge ofdomestic and international quality system regulations and the ability to drive continuous improvement in regulated environments.

• Strong foundation instatistical methods, including normality testing, capability analysis, tolerance intervals, andtest method validation (MSA, Gage R&R).

• Advanced proficiency inrisk management per ISO 14971, includingFMEA, system‑level risk analysis, and hazard analysis (expertise in at least one area required).

• Ability to develop and evolvecomplex quality concepts, standards, and methodologiesbased on sound quality engineering principles.

• Strong knowledge ofmedical device and/or combination product manufacturing operations.

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 ormentaldisability, 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 contactApplicantAccommodations@gilead.com for assistance.

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