Compliance and Quality Assurance Specialist
5 days ago
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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