Quality Engineer

Responsibilities: Test Method Validation and Process Validation in support of design transfer and production transfer.
Measurement System Analysis (MSA) & Gage R&R (repeatability & reproducibility) Process risk documentation, including updates to PFMEAs.
Team communications Other duties, as required.
Requirements: 5+ years of relevant Quality Engineering experience in the medical device industry Strong understanding of and extensive experience planning, executing and documenting test method validation and process validation in the medical device industry Measurement System Analysis and Gage R&R expertise Excellent verbal and written communication skills, including proven experience creating and updating validation and risk documentation and specific experience writing PFMEA content