Supplier Quality Manager [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.

The Supplier Quality Manager for Radiometer is responsible for securing reliable and compliant products during production, storage and shipping of products. This is done by cooperating, supporting, facilitating, training and communicating towards obtaining the best results with partners in Supply Chain, Operations, Warehousing and supporting functions at the site in DK as well as the US, Poland, Basel, Finland and China.

This position is part of the Quality Assurance located in Poland and will 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 Supplier Quality Team and report to the Senior Manager QA, SQM responsible for managing a global team with colleagues located in Denmark, Poland and China. The team supports the operation including the supply chain. If you thrive in a dynamic role and want to work to build a world-class securing reliable and compliant products during production, storage and shipping of products organization—read on.

In this role, you will have the opportunity to:

  • QA oversight on suppliers and Contract Manufactures (CMOs) for Radiometer and ensuring that the delivered products comply with valid quality standards and legal requirements

  • Plan and perform Supplier/CMOs Audits including follow up on audit findings

  • Establish and maintain Quality Agreement with Suppliers and Contract Manufacturers (CMO)

  • Partner with stakeholders and collaborate to ensure compliance related to SQM and ensure OTD

  • Lead improvement projects involving SQM area

The essential requirements of the job include:

  • M.Sc. or B.Sc. degree in engineering or has pharmaceutical background, other education at university level relevant for QA work could be accepted

  • Specialist in SQM: Minimum 5 years’ experience in Medical Device industry or Pharma industry, with at least 2 years’ experience in the area of Supplier Quality Management. This includes experience with performing Quality Agreements, Supplier Audits and classification of suppliers/components and Supplier approval

  • Lead Auditor in 13485:2016

  • Knowledge of regulatory demands and standards: MDD/MDR, IVD/IVDR, ISO 13485, MDSAP, FDA legislation

  • English at communicative level

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

Experience with Medical Device industry and Lead Auditor will be a plus

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.

This job is also eligible for bonus/incentive pay.

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 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.

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