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BioTalent

Senior Quality Assurance Engineer - Medical Devices

BioTalent, Alameda, California, United States, 94501

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Join Our Team: Senior Quality Assurance Engineer - Class II/III Medical Devices No Sponsorship Available Onsite Position | Salary: $120K-$150K Base + Bonus + Stock Options About Us:

We are a leading innovator in the medical device industry based in the Bay Area, and we are seeking a highly skilled Senior Quality Assurance Engineer to join our dynamic team. Your Role:

In this key position, you will contribute to the development and commercialization of Class II/III medical devices, ensuring they meet the highest quality standards. Key Qualifications: Proficient in Sterilization Techniques (EO, Radiation, Packaging Validation) Expertise in Biocompatibility (ISO 10993) Strong background in Risk Management (ISO 14971) Experience with Design Assurance, Design Controls, and compliance with 21 CFR 820 / ISO 13485 This is a fantastic opportunity to work in a collaborative and innovation-driven environment that supports your professional growth. If you are a Bay Area professional with a robust quality engineering background in medical devices and are interested in this onsite opportunity, I encourage you to reach out to learn more!