Location
Irvine, California, United States
Posted
May 11, 2026
Job Description
Job Description:
Roles & Responsibilities:
- 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 process vali...