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Danaher Corporation QA Specialist, SQM in Bronshoj, Denmark

Here at Radiometer we have a high focus on our supplier quality and are growing our Supplier Quality Management (SQM) team. Do you have experience working with SQM within pharma or medical devices? And do you want to be a great team that focuses on helping and developing each other? Then this might be the role for you!

The team

The QA team has a significant role in securing reliable products during production, storage, and shipping. 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.

The position is located in Denmark and reports to our danish Senior Manager and is part of QA Engineering and Operations is a department with 37 employees divided into 5 teams.

Key responsibilities

Ensures compliance to regulatory requirements for Supplier Quality Management in corporation with the Procurement and Supplier teams in Manufacturing.

Contribute to the global QA SQM process to approve and monitor suppliers in close corporation with Procurement.

SQM partner for R&D and Procurement.

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

  • Be part of the 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.

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

Requirements

  • Minimum 3 years experience with Supplier Quality Management within Medical Devices or Pharma

  • Negotiation and change management skills

  • Presentation skills to all levels of the organization

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

  • Experience with performing Quality Agreements and Supplier Audits. Lead Auditor in 13485:2016 is an advantage

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

Our offer

An outstanding opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad we have hardworking colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer 'freedom with responsibility', flexibility, opportunities for training and career development, and a plethora of staff benefits.

Application

We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. Any important questions regarding the position can be directed to the responsible recruiter David A. Lyngh at davia@radiometer.dk.

Radiometer

In our line of work, life isn’t a given - it’s the ultimate goal!

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgment that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all +4100 colleagues across 37 countries are committed and dedicated to helping realize life’s potential. Developing on a personal and professional level is of high importance for everyone here and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.

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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