Manager, Quality Assurance (Design)

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.

The Manager, Quality Assurance (Design) for Leica Biosystems is responsible for design assurance and leadership within the QARC team to support the Newcastle site to deliver and sustain advance staining reagents and diagnostic assays in the clinical market. This role will oversee multiple project deliverables, as well as provide review and guidance for risk management, verification and validation activities related to the development projects and the sustainment of documentation under IVDR.

This position is part of the Quality Assurance & Regulatory Compliance department located in Newcastle-upon-Tyne, UK and will be an on-site role. 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, QARC responsible for ensuring that the business has the infrastructure and skilled QARC competencies to meet or exceed requirements. If you thrive in a fast paced, leadership role and want to work to build a world-class Quality Assurance & Regulatory Compliance organization-read on.

In this role, you will have the opportunity to:

• Leadership and management responsibilities for QA professionals covering design assurance and QMS duties.
• Responsible for planning, organizing, and conducting duties related to design assurance.
• Manage business-critical new product development projects and external partnership programs, including ensuring that state-of-the-art requirements are maintained throughout the product lifecycle.
• Hire, develop, engage and retain highly capable Quality Officers and Specialists ensuring that each associate is meeting performance requirements and that each people leader role and critical position has an identified successor with a targeted and robust development plan.
• Participate in cross-functional teams at various phases of the development cycle as the Design Assurance representative. Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Regulatory Assurance, Research & Development, Product/Program Management) to achieve project goals and meet timelines.
• Collaborate with Regulatory Affairs to Input into the regulatory strategy and plans for clearance/approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD and Companion Diagnostics markets, including providing input into 510(k), PMA and companion diagnostic submissions.
• Use Danaher Business System (DBS) tools on a regular basis to continually improve the QA design assurance function.

The essential requirements of the job include:

• Working knowledge of design controls for regulated products.
• Experience in IVD medical device new product development and design controls.
• Prior management experience or demonstration of leadership skills.
• Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, MDSAP and ISO 13485.

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

• IVD medical device regulatory affairs experience a distinct advantage.

Join our winning team today. Together, we\’ll accelerate the real-life impact of tomorrow\’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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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.