Medical Device QA Compliance Specialist

1 day ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Innovate with Radiometer Danmark / Danaher to shape the future of diagnostics.

About Us

At Radiometer Danmark / Danaher, we bring together science and technology to accelerate real-life impact. We partner with customers across the globe to help them solve complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next in Life Sciences, Diagnostics, Biotechnology, and beyond.

Career Opportunity

We're seeking a Medical Device QA Compliance Specialist to join our team in Brønshøj, Denmark. As a key member of our Quality Management System (QMS) team, you'll be responsible for handling QMS processes and ensuring compliance within the organization.

This is an onsite role, and you'll be part of the RAQA organization. At Radiometer Danmark / Danaher, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. You'll report to the Senior Manager of QMS Compliance and work closely with cross-functional teams to drive quality excellence.

Key Responsibilities
  • Handle QMS and supporting processes to ensure compliance
  • Share knowledge and maintain 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

To succeed in this role, you'll 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
Benefits and Salary

The estimated salary for this position is around €60,000 - €80,000 per year, depending on experience. We also offer a comprehensive benefits package, including health insurance, pension plan, and opportunities for professional growth and development.



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