Senior Quality Assurance Specialist

2 days ago


Tarrytown, New York, United States Katalyst HealthCares & Life Sciences Full time
Job Title: Senior Quality Engineer

Katalyst HealthCares & Life Sciences is seeking a highly skilled Senior Quality Engineer to support our client in the EU MDR program.

Responsibilities:
  • Review technical files from a quality perspective to ensure compliance with the EU MDR standard.
  • Validate test methods, manage risks, and ensure usability of medical devices.
  • Collaborate with cross-functional teams to identify and address quality-related issues.
  • Develop and implement quality procedures to ensure compliance with regulatory requirements.
  • Provide expert guidance on EU MDR regulations and industry best practices.
Requirements:
  • Proven experience with EU MDR regulations and compliance.
  • Strong background in test method validation, risk management, and usability.
  • Experience working with orthopedic devices or tissue-based products.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.


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