Job Description


Job Summary:
  • Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA.

  • The role focuses on process validation, risk management, and ensuring compliance with applicable medical device quality and regulatory standards through cross-functional collaboration.


    • Roles & Responsibilities:
  • Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.

  • Perform and analyze IQ, OQ, and PQ qualifications along with other validation activities.

  • Lead PFMEA sessions to identify, assess, and mitigate process and product risks.

  • Design, validate, and verify test methods to ensure product quality and regulatory compliance.

  • Analyze validation data and recommend process optimizations based on results.

  • Collabo...

    • Ready to Apply?

    Take the next step in your AI career. Submit your application to Katalyst HealthCares & Life Sciences today.

    Submit Application