QA Compliant Process 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 QA Complaint Process Specialist for Radiometer is responsible for maintaining and improving the complaint management process and system working closely with our stakeholders in sales, operations, IT, and QA/RA.
This position is part of the QA Operations Manufacturing and Complaint team located in Copenhagen and will be hybrid.
You will be a part of our complaint handling team and you will report to the Director, QA OPS Manufacturing and Complaints responsible. If you thrive in a dynamic and innovative environment role and want to work to build an excellent complaint handling process—read on.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Bachelor’s or master’s degree in a technical field such as electrical engineering, chemical engineering, mechanical engineering, chemistry, biochemistry, etc.
• Fluent in English (spoken and written).
• A minimum of 5 years in medical device or pharma manufacturing in a QA, operations, R&D, supply chain, or regulatory affairs role.
• Experience with regulations such ISO 13485 or FDA QSR 820.
• Experience with stakeholder management in a matrix organization.

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

• Handling of customer complaints.
• LEAN methodology (5S, kaizen, value stream mapping, standard work).
• Writing procedures and instruction.

• Maintain and improve the global complaint process and procedures for Radiometer.
• Understand our electronic complaint handling system and participate in improvement activities and projects in collaboration with QA, IT, and our Field Service organization.
• Train others in important aspects of complaint handling such as investigation and root cause analysis.
• Present the complaint handling process in internal and external audits.
• Manage extensive cross function collaboration with functions such as RA/QA, IT, R&D, and Sales.
• Work across sites with colleagues in Poland, Finland, USA, Switzerland, and China.