QA Specialist, Validation - Stargard, Polska - Danaher

Opis

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, Validation for Radiometer is responsible for assuring quality of processes, which undergo validation, which could involve machines, test methods, software, etc.

This position is part of the QA Validation Team located two places: in Stargard, Poland and Copenhagen, Denmark. Position is considered to be hybrid. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the QA Validation Team and report to the Senior Manager, QA responsible for Validation in Copenhagen and in Stargard, but also Global Engineering Changes, Country Specific Labelling, Sterilization and Product Lifecycle Management. If you thrive in a supporting role and want to work to build a world-class quality organization—read on.

In this role, you will have the opportunity to:

• Support software, process, test method, or supplier validations
• Train users in validation process
• Improve existing processes and pursue delivering solutions to comply with new regulations
• Collaborate with colleagues placed across Europe, Asia, and America

The essential requirements of the job include:

• Quality and regulatory mindset (ISO 13485:2016, QSR Part 820 and Part 11 knowledge and practice)
• 3 years of experience in QA and medical devices industry
• 1 year of experience in validation and revalidation processes
• MSc of Technical University, degree in engineering
• Understanding and experience in risk analysis process (ISO 14971:2019 knowledge and practice)
• Effective communication in English

It would be a plus if you also possess previous experience in:

• Experience in auditing, either being auditee, or being auditor
• Experience with software solutions

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.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's 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 what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

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.