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.

Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.

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

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.

For Jobs In The United States

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 ApplicantAccommodations@gilead.com 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 levelNot Applicable Employment type Employment typeFull-time Job function Job functionQuality Assurance IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Gilead Sciences by 2x Get notified about new Senior Quality Engineer jobs in San Francisco Bay Area . San Francisco, CA $160,200.00-$187,700.00 2 weeks ago San Francisco Bay Area $150,000.00-$170,000.00 2 weeks ago Pleasanton, CA $86,700.00-$173,300.00 1 week ago Medical Device Quality Engineering Manager Alameda, CA $145,000.00-$214,000.00 2 weeks ago Medical Device Senior Quality Engineer (Electromechanical) Alameda, CA $125,000.00-$175,000.00 1 week ago Quality Engineering Manager (Multiport Da Vinci - Endoscopes) Sunnyvale, CA $132,600.00-$224,400.00 2 weeks ago Sr. Quality Engineer - Multiport Da Vinci Instruments Sunnyvale, CA $126,100.00-$213,500.00 2 weeks ago Alameda, CA $125,000.00-$175,000.00 2 weeks ago Quality Engineering Manager - Multiport Da Vinci (I&A) Sunnyvale, CA $132,600.00-$224,400.00 1 week ago San Francisco, CA $140,000.00-$170,000.00 1 hour ago Alameda, CA $145,000.00-$214,000.00 1 week ago San Jose, CA $165,000.00-$190,000.00 1 week ago San Mateo, CA $195,500.00-$293,300.00 4 weeks ago Quality and Compliance Engineer - Fremont, CA Fremont, CA $75,000.00-$90,000.00 5 days ago San Jose, CA $108,000.00-$135,000.00 1 week ago Manager, HW Compliance, Safety, and Validation Engineering, eero QualityManager, Software Engineering Quality (Cortex Cloud)Manager, HW Compliance, Safety, and Validation Engineering, eero Quality San Francisco, CA $135,900.00-$234,900.00 5 days ago Senior Software Quality and Compliance Engineer - AD/ADAS Systems Mountain View, CA $100,000.00-$150,000.00 4 days ago Mountain View, CA $100,000.00-$150,000.00 1 day ago Senior/Staff Power Electronics Manufacturing EngineerConsultant - Structural Engineering & Analysis San Jose, CA $112,160.00-$140,200.00 5 months ago Santa Clara, CA $108,000.00-$224,250.00 1 day ago San Francisco Bay Area $130,000.00-$155,000.00 20 hours ago Redwood City, CA $112,700.00-$155,000.00 2 weeks ago Pleasanton, CA $135,500.00-$183,300.00 1 day ago Brisbane, CA $140,000.00-$160,000.00 5 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr