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Mechanical Medical Device Quality Expert

Jobleads-US
Los Gatos, CA Full Time
POSTED ON 4/5/2025
AVAILABLE BEFORE 5/5/2025

Requirements

To be successful in this role, you will need:

  • Strong proficiency in Process and Test Method Validation, including statistical techniques and data analysis.
  • Demonstrated experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
  • Proven experience of Quality Systems of mechanical medical devices and/or interventional cardiology products.
  • Working and demonstrated knowledgeable of medical device regulations, including FDA QSR, 13485, EU MDR etc.

Education & Work Experience:

  • S. or higher in Biomedical, Mechanical or Systems Engineering or equivalent relevant work experience.
  • 6 years of experience in a quality engineering role.

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