Senior Quality Engineer
5 days ago
This is an exciting opportunity to join Gilead Sciences as a Senior Quality Engineer - Combination Products. As a key member of our team, you will be responsible for providing quality oversight for commercial stage products, including design transfer. You will work closely with the design and development team to ensure that our combination products meet the highest quality standards.
Key Responsibilities:
Provide quality oversight for commercial stage products, including design transfer
Create and revise SOPs to support combination product quality governance in the commercial stage
Evaluate design changes and provide quality input to support continuous improvement initiatives
Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards
Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards
Requirements:
6+ years of relevant experience and a Bachelor's degree in a Science or Engineering related field; or 4+ years of relevant experience with a Master's degree in a Science or Engineering related field
Medical device experience preferred
Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards
Previous experience with combination devices is preferred (i.e., Autoinjectors, co-packaged kits, pre-filled syringes)
Quality experience in both clinical and commercial products
Strong project management and process improvement skills
What We Offer:
Gilead Sciences offers a competitive salary range of $133,000 - $172,000, depending on experience and qualifications. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
About Gilead Sciences:
Gilead Sciences is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Our company operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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