Senior Quality Engineer
Element BiosciencesSan Diego, California, United States
Posted December 22, 2025
104000 - 137000 USD year
Full Time
About the Company
Element Biosciences is a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment.
Job Description
Element Biosciences is seeking a Senior Quality Engineer to play a pivotal role in maturing their Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on their on-market products.
Requirements
- Bachelors degree in Engineering, Biology, or related science field
- Minimum of 5 years' experience in the medical device (Class I-II) or other regulated industry
- Experience with ISO13485 and ISO 14791 is required. Experience with EU MDR, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred
Benefits
- Stock options
- Discretionary annual bonus
- No cost health insurance plans
- 401k with company match
- Flexible paid time off
