Danaher Corporation QA Specialist (Validation) in Stargard, Poland
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.
Due to the development of organization as well as meeting our Customers' expectations we are currently looking for an experienced QA Specialist to support validation. The job is located in Stargard, Poland and is hybrid.
Main responsibility will be to provide 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.
In this role you would be responsible for supporting validations dedicated to:
test methods used for verification of manufactured devices,
tools and products software validation,
process validations (including on-site and at supplier: moulding, dispensing, gluing, welding, etc.).
Validations are widely used within Radiometer for new projects and products, as well as for maintaining current production and introduction of optimizations to them. Therefore, by joining our team you will have a chance to cooperate with people from across whole company.
Ideal candidate for this role should have:
Experience in validation and revalidation processes
3 years of experience in QA, preferably in medical devices industry
Quality and regulatory mindset
MSc of Technical University, degree in engineering
Understanding and experience in risk analysis process
ISO13485:2016 and QSR Part 820 and Part 11 knowledge and practice will be an asset
QA support in relation to Projects
Supervision in preparation and approval of documentation related to validation/revalidation activities
Risk analysis in relation to material/supplier changes
Internal projects in QA function
What we offer
You will get a unique opportunity for personal and professional development in a fast-paced and dynamic environment with a distinct respect for the individual. Both in Poland, 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.
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.