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Principal Specialist, Quality Assurance

3 months ago

Amersham Bucks, United Kingdom Danaher Full time

Leica Biosystemsâ mission of âAdvancing Cancer Diagnostics, Improving Livesâ is at the heart of our corporate culture. Weâre 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, youâre 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, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs biggest health challenges. 

The Principal Specialist, Quality Assurance (Design) for Leica Biosystems is responsible for delivering and sustaining advance staining reagents and diagnostic assays into the Clinical Market.

This position is part of the QARC Department located in Newcastle-upon-Tyne and will be a hybrid position. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the QA Team and report to the Manager, Quality Assurance (Design) responsible for supporting Design Control activities to bring new products to market. If you thrive in a multifunctional and fast paced role and want to work to build a world-class Quality organizationâread on.

In this role, you will have the opportunity to:

  • Provide leadership and responsible for the planning, organizing, and conducting duties related to Design Quality but may also support Quality Systems and Supplier Quality ensuring executions of tasks ensuring the delivery to the business is within budget and on schedule.

  • To work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).

  • May lead functional teams or projects with moderate resource requirements, risk, and/or complexity.

  • Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.

  • Provides technical/SME leadership across or within function, working with other LBS and Danaher sites.

The essential requirements of the job include:

  • Quality management/leadership experience with IVD medical devices. 

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

  • Experience in IVD medical device NPD, design controls and risk management

  • Experience in supplier quality, IVD reagent manufacturing, design transfer processes

  • Bachelorâs degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance,

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

  • Supplier Auditing and/or Quality Assurance.

  • IVD medical device regulatory affairs experience a distinct advantage.

  • Experience with the MDSAP Programme.

  • Experienced in delivering higher classification medical devices and/or companion diagnositic products to market.

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.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs 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. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.