Senior Quality Engineer II – Combination Product Development

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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.
 

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Job Description
 

Gilead Sciences is looking to hire a Sr Quality Engineer for the Combination Product Development team.

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 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 8+ years of relevant experience, OR a Master's degree in a relevant field with 6+ 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.

· Possess a strong foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, Gage R&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.

· Excellent verbal, written, and interpersonal communication skills

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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 ApplicantAccommodations@gilead.com for assistance.
 

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.