Senior Quality Assurance Specialist

4 weeks ago


Tarrytown, New York, United States Katalyst HealthCares & Life Sciences Full time
Job Summary:

Katalyst HealthCares & Life Sciences is seeking a Quality Assurance Expert to support the EU MDR program. The ideal candidate will have experience with EU MDR, test method validation, risk management, and usability.

Responsibilities:
  • Review technical files from a quality perspective.
  • Ensure compliance with the EU MDR standard in areas such as test method validation, risk management, and usability.
  • Collaborate with the client to provide additional support for the EU MDR program.

Requirements:
  • Experience with EU MDR.
  • Experience with test method validation, risk management, and usability.
  • Orthopedic device or tissue-based experience.


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