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Senior Quality Assurance Specialist

2 months ago

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

Katalyst HealthCares & Life Sciences is seeking a highly skilled Senior Quality Engineer to join our team.

Responsibilities:
  • Support the EU MDR program by reviewing technical files from a quality perspective.
  • Ensure compliance with the EU MDR standard by reviewing test method validation, risk management, and usability.
  • Collaborate with the team to identify and address quality-related issues.
  • Develop and implement quality assurance processes to ensure regulatory compliance.
  • Provide expertise on EU MDR regulations and guidelines.
Requirements:
  • Experience with EU MDR regulations and guidelines.
  • Experience with test method validation, risk management, and usability.
  • Orthopedic device or tissue-based experience.
  • Strong understanding of quality assurance principles and practices.
  • Excellent communication and collaboration skills.