Job Description


Summary:
  • Perform Quality Engineering activities related to product development and ongoing cleanroom build support

  • Ensure NPD processes comply to quality system and applicable regulatory standards.

  • Update risk management and design control files. Maintain relevant quality documentation.

  • Develop and execute test methods validations and qualification plans.

  • Support design verification and facilitate process validation and commercialization activities related to multi-site transfer.

  • Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.

  • Other duties assigned by Leadership.
    • Roles & Responsibilities:
  • Proficient understanding of medical device operations and/or manufacturing processes. Medical Device experience strongly preferred.

  • Relevant experience in product development, quality assurance, and/or related f...

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