Sr Quality Engineer

Katalyst Healthcares & Life Sciences • Irvine, California, United States • Posted May 16, 2026

About the Role

Job Summary:

  • The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.

  • The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.


Roles & Responsibilities:


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

  • Ensure NPD processes comply with the quality system and applicable regulatory standards

  • Update risk management and design control files and maintain relevant quality documentation

  • Develop and execute test method validations and qualification plans

  • Support design verification and facilitate proce...