Product Quality Assurance Engineer

Emeryville, CA
Business Operations /
Full Time /
Hybrid

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Product Quality Assurance Engineer

  • How many years of experience do you have in a Quality Assurance or Quality Systems role within a regulated industry (e.g., medical devices, pharmaceuticals, biotech)?
  • How many year of experience do you have working with GxP and Computer Systems Validation (CSV) guidelines such as 21 CFR Part 11, Annex 11, GMP, or ICH Q9?
  • Are you experienced with complaint handling and CAPA investigations per ISO 13485 or FDA requirements?
  • How many year of experience you have supporting the creation or maintenance of product design documents (e.g., DMR, DHF, Design Inputs/Outputs, Traceability Matrices)?
  • How many years of experience do you have working in medtech and healthtech companies?
  • What is your annual salary expectation

U.S. Equal Employment Opportunity information   (Completion is voluntary and will not subject you to adverse treatment)

Our company values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment.