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Danaher Corporation Senior QA Specialist, SQM (f/m/d) in Stargard Szczecinski, Poland

Due to the development of organization as well as meeting our Customers expectations we are currently looking for an experienced Senior QA Specialist, Supplier Quality Management (f/m/d) located in Stargard, Poland.

The QA team has a significant role in 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 and Polish production sites.

Your main responsibility will be to ensure compliance to regulatory requirements for Supplier Quality Management in corporation with the Sourcing and Supplier teams in Manufacturing. You will contribute to the global QA SQM process to approve and monitor suppliers in close corporation with Sourcing.

Responsibilities

  • Partner with Supplier organization to ensure continuous compliance to ISO 13485:2016 requirements and other relevant regulations and ensure efficient QA processes

  • Drive writing and maintaining Quality Agreements with Contract Manufacturers, Suppliers and Distributors

  • Be part of Supplier audit team and perform Supplier Audits as lead auditor

  • Drive global QA SQM activities

  • Collaborating closely with Operations management to ensure timely and compliant product deliveries

  • Use a lean process view to constantly improve quality processes to become efficient, lean and in compliance with regulations

  • Participate in Supplier Management team meetings

  • Participating in quality training activities

  • Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA systems

  • Providing guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment

    Requirements

  • M.Sc. or B.Sc. degree in engineering or pharmaceutical background

  • Negotiation and change management skills

  • Presentation skills to all levels of the organization

  • Minimum 5 years experience with Supplier Quality Management within Medical Devices or Pharma

  • Experience and practical knowledge about quality assurance for medical device products and components

  • Broad process knowledge (production as well as R&D experience) preferred

  • Experience with performing Quality Agreements and Supplier Audits

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

  • Work Experience from other Medical Devices or IVD companies in a similar role

  • Lead Auditor in 13485:2016 is an advantage

  • Polish and English fluently in writing and speaking

  • Power and drive to ensure execution and results

  • Negotiation and change management skills

  • Travelling ability up to 25% of working time, mainly to Denmark and long - distance trips (China)

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.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.

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