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Senior Quality Engineer

7 days ago

Tarrytown, New York, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities and Requirements: Our client is restarting the EU MDR program and needs some additional support and the amount of work they will need to have completed and reviewed over the next few months. The candidates will be reviewing technical files from a quality perspective. The areas they will be reviewing are test method validation, risk management, and usability to make sure they are compliant to the EU MDR standard. Must have experience with EU MDR. Must have experience with test method validation, risk management, and usability. Must have orthopedic device OR Tissue-based experience.