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...
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