Quality Engineer (Medical Device is a MUST)
Proven Recruiting
Quality Engineer (Medical Device is a MUST), Contract possible contract to hire, San Diego, CA , $50–$75/hr Looking for a contract role where you can drive quality, validation, and investigation work end-to-end? Our client, an innovative medical device organization, is seeking a hands-on Quality Engineer to support testing, compliance, and CAPA efforts with strong visibility across R&D and manufacturing. Who you are:
- Bachelor’s degree in Engineering with 3-7+ years of experience in medical devices or a regulated ISO/cGMP/GLP environment
- Strong experience with validation (IQ/OQ/PQ), statistical methods (Six Sigma, DOE), and complaint/CAPA investigations
- Working knowledge of ASTM, ISO, and ICH standards with a strong attention to detail and problem-solving mindset. Prefer class 3 medical device experience.
- Develop and execute validation protocols, test methods, sampling plans, and calibration procedures
- Lead product investigations, CAPAs, and supplier quality issues, including complaint analysis and trend evaluation
- Perform statistical analysis and support risk management, audits, and cross-functional quality initiatives
Vacancy posted more than 2 months ago
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