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 QA Specialist, QMS Compliance for Radiometer is responsible for ensuring that the QMS is maintained (acting as subject matter expert and administrator) in accordance with applicable standards and regulations, drive and optimize supporting processes, conduct internal audits, and support external audits.
With reference to the Manager, QMS Compliance, you are part of a team of highly skilled and engaged colleagues. QMS Compliance has a significant cross-functional role in Radiometer, in Denmark and globally at Radiometer Contract Manufacturers. We cooperate, facilitate, train, and communicate to seek solutions by being close to our partners.
To become successful, you must have a talent for creating good relations and facilitate improvement. You are an excellent team player but are confident in working on your own.
This is a unique opportunity for personal and professional development in a fast-paced and dynamic environment with a distinct respect for the individual. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people’s lives. We offer you ‘freedom with responsibility’, and a wide range of staff benefits.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• The preferred candidate holds a master’s degree 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, IVD, MDD, and FDA legislation) from QA job function
• Experience with Front Office / Back Office roles during external audits
• Fluent Danish and English

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