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Danaher Corporation Senior Manager, Quality Assurance in Newcastle Upon Tyne, United Kingdom

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems 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.

Position Summary

The Senior Manager, Quality Assurance for Leica Biosystems is responsible for the leadership and management of Quality Assurance professionals covering Design Quality, Supplier Quality and Quality Management.

This position is part of the Quality and Regulatory Affairs department located in Newcastle Upon Tyne, United Kingdom and will be hybrid. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the Quality Assurance team and report to the Director, Quality Assurance and Regulatory Compliance, responsible for using knowledge and experience to identify, solve and document problems and risks within the quality system, maintaining strong relationships with internal and external stakeholders, and sustaining working knowledge of relevant regulations and quality system requirements that affect the business. If you thrive in a fast-paced leadership role and want to work to build a world-class Quality organization — read on.

In this role, you will have the opportunity to:

  • Maintain and continuously improve the site quality management system to ensure compliance with all applicable regulatory requirements for in vitro diagnostics medical devices, including CAPA, non-conformances, change controls, quality agreements, document control, and risk management.

  • Collaborate with the procurement team to execute supplier quality standards, supplier quality agreements, supplier evaluation and selection, supplier audits, management of SCAR process, and achievement of key metrics.

  • Serve as the Quality Assurance representative for design control and risk management of new product development projects and device change initiatives, and support design quality assurance for cross-site projects.

The essential requirements of the job include:

  • Bachelor’s or Graduate degree in science, medical, or technical field and experience with increasing responsibility in medical device Quality Assurance.

  • Certification in medical device Quality Assurance via on-the-job training and relevant seminars.

  • Experience conducting and hosting quality system audits/regulatory inspections, including the Medical Device Single Audit Program.

  • Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.

  • Experience in supporting best practice safety performance levels and ensuring business complies with all relevant EHS regulations.

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

  • Communicating difficult or sensitive information and working to build consensus.

  • Managing and developing a team of quality management professionals by providing coaching and career development support; mentoring colleagues with less experience.

  • Identifying, analyzing, and mitigating risk (e.g., product, material, compliance, supply) in a cross-functional environment.

At Leica Biosystems 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 Leica Biosystems 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.