Senior Software Validation Manager
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 Senior Software Validation Manager for Radiometer is responsible for leading a team, which provides quality assurance services to ensure the integrity of products, services provided to clients, support business and customer needs, and comply with government regulations, industry, and Operating Company standards.
This position is part of the QA Validation Team located in Copenhagen, Denmark and Stargard, Poland. The role is based in Stargard and hybrid solution is acceptable. 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, Engineering Changes and Country Specific Labelling. If you thrive in a multifunctional role and want to work to build a world-class quality organization - read on.
In this role, you will have the opportunity to support validations dedicated to:
Lead Software Validation Team (3 associates)
Support software validations
Train users in validation process
Improve existing processes and pursue delivering solutions to comply with new regulations
Create strategy for next years, including deployment of AI, new eQMS software, etc.
The essential requirements of the job include:
Proven record of leadership skills
Quality and regulatory mindset (ISO 13485:2016, QSR Part 820 and Part 11 knowledge and practice)
5 years of experience in QA and medical devices industry
3 years’ experience in validation and revalidation processes
MSc of Technical University, degree in engineering
It would be a plus if you also possess previous experience in:
Experience in auditing, either being auditee, or being auditor
Experience in risk analysis
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.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.