Principal Specialist, Quality Assurance (Design)

Danaher

  • Newcastle
  • Permanent
  • Full-time
  • 21 days ago
Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Leica Biosystems, one of 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.Learn about the which makes everything possible.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 reports to the Director, Quality Assurance & Regulatory Compliance and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.In this role, you will have the opportunity 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).
  • Provide Design Control leadership across or within function, working with other LBS and Danaher sites.
  • Work independently and with project team members to develop and improve processes to reduce variability and increase robustness throughout the development and product lifecycle for multiple projects.
  • 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.
The essential requirements of the job include:
  • Strong working knowledge of Design Controls & Design/Development practices for regulated products.
  • Extensive experience in IVD medical device new product development and design controls.
  • Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP.
  • Quality leadership experience with IVD medical devices.
  • Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance
Travel, Motor Vehicle Record & Physical/Environment Requirements:
  • Ability to travel – up to 20% travel
It would be a plus if you also possess previous experience in:
  • Experienced in delivering higher classification medical devices and/or companion diagnostic products to market.
  • Supplier Auditing and/or Quality Assurance.
  • Experience with the MDSAP Programme
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.For more information, visit .

Danaher