Senior Quality Engineer II - Combination Product Development

Senior Quality Engineer II - Combination Product Development

Join to apply for the Senior Quality Engineer II - Combination Product Development role at Gilead Sciences

Senior Quality Engineer II - Combination Product Development

Join to apply for the Senior Quality Engineer II - Combination Product Development role at Gilead Sciences

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).
  

Basic Qualifications

• Bachelor's degree in engineering or a scientific discipline with at least 8 years of relevant experience, OR a Master's degree in a relevant field with at least 6 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
  

Preferred Qualifications

• 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.
  

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
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees And Contractors
Please apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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