QA Compliant Process Specialist

In our line of work, life isnât a given - itâs 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 weâre located. Creating impactful innovations like ours, doesnât 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, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs 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 processâread on.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include:

• Bachelorâs or masterâs 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.

Application

We continuously assess candidates and invite them for interviews, so please donât hesitate to write and send in the application.

We encourage you to apply before end of business on 5th May 2024. If you have questions, feel free to contact Director QA Manufacturing, Inge Mygind Aagaard at inge.mygindaagaard@radiometer.dk. We look forward to seeing your application.

We thank you for your interest. Please read our Applicant Data Privacy Notice carefully here.

Hybrid

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. 

Danaher

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.