Danish speaking QA/QMS Specialist

at  Radiometer

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Danish speaking QA Specialist for QMS Compliance in Radiometer is responsible for handling the quality management system and supporting processes as a crucial role to ensure compliance in the organization.
This position is part of the RAQA organization located in Brønshøj, and will be hybrid of on-site and remote. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. You will be a part of the QMS Compliance team and report to the Senior Manager of QMS Compliance. If you thrive in a cross functional and fast paced role and want to work to build a world-class QA organization—read on.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• 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

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Experience with Front Office / Back Office roles during external audits

• 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.