Danish Speaking QA/QMS Specialist

4 weeks ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark / Danaher is seeking a highly skilled Danish speaking QA/QMS Specialist to join our team. As a key member of our Quality Management System team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.

This role will involve handling quality management processes, supporting processes, and maintaining expertise within applicable standards and regulations. You will also participate in and drive smaller projects in the RA/QA function with manageable risks and resource requirements.

The ideal candidate will have a strong background in quality management, with a minimum of 5 years of experience in a QA job function. You will also have excellent communication and stakeholder management skills, as well as master spoken and written English and Danish language skills.

Key Responsibilities:

  • Handling of QMS and supporting processes
  • Sharing knowledge and maintaining expertise within applicable standards and regulations
  • Participate in and drive smaller projects in the RA/QA function with manageable risks and resource requirements
  • Guide the organization during External Audits
  • Plan, facilitate, conduct training of the organization

Requirements:

  • 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

What We Offer:

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package

How to Apply:

If you are a motivated and experienced QA/QMS Specialist looking for a new challenge, please submit your application, including your resume and a cover letter, to us. We look forward to hearing from you.



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