Compliance and Quality Assurance Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time
Job Overview

Radiometer Danmark is a leading provider of diagnostic equipment and solutions. We are committed to improving global healthcare with reliable, fast, and easy patient diagnoses.

We are seeking a highly skilled Danish speaking QA/QMS Specialist to join our team in Brønshøj, Denmark. In this role, you will be responsible for handling the quality management system and supporting processes as a crucial part of ensuring compliance in the organization.

The key responsibilities of this role include:

  • Handling QMS and supporting processes
  • Sharing knowledge and maintaining expertise within applicable standards and regulations
  • Participating in and driving smaller projects in the RA/QA function
  • Guiding the organization during External Audits
  • Planning, facilitating, and conducting training of the organization

To succeed in this role, you will need:

  • MSc in Engineering, Pharmacy, Biology, Biochemistry or similar
  • Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics
  • Min. 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVDD/IVDR, MDR, and FDA legislation) from QA job function
  • Excellent communication and stakeholder management skills
  • Master spoken and written English and Danish language skills


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