Senior Principal Specialist, Quality Assurance

3 weeks ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Danaher Corporation Full time

You will be a part of the Quality Assurance team and report to the Manager, Quality Assurance (Design). You will be responsible for applying in-depth knowledge, experience, expertise in multiple areas of medical device quality assurance, guiding the Quality Assurance design organisation in key Design Control activities, and collaborating cross-functionally with internal and external business partners on new product development and strategic initiatives to drive project results. If you thrive in a fast paced, multifunctional role and want to work to build a world-class Quality Assurance organization, read on.

In this role, you will have the opportunity to:

  • Serve as Quality Assurance lead for Design Control covering business-critical new product development projects and external partnership programs, including ensuring that state-of-the-art requirements are maintained throughout the product lifecycle.
  • Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Regulatory Affairs, Research and Development, Product and Program Management) to achieve project goals and meet timelines.
  • Critically review and approve analytical and clinical study protocols and reports to assess quality, identify gaps, and provide mitigations that support successful new product development, bringing high-quality product to market.
  • Define 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 and acting on regulatory intelligence changes to ensure minimal impact to current and future portfolio.
  • Mentor and coach LBS Quality Assurance professionals in their development and support building team capabilities.

The essential requirements of the job include:

  • Extensive experience in medical device industry covering Innovation and Design Control.
  • Proven experience supporting submissions for high-complexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA.
  • Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, and the MDSAP programme.
  • Substantial experience in commercial product development including transfer of complex feasibility projects into product commercialization.
  • Experience in support of New Product Development for high complexity products with experience supporting complex clinical trials and Pharma partner integration.

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

  • The IVD, Companion Diagnostics, and/or stand-alone software/digital fields.
  • Collaborating with external stakeholders, such as suppliers, and academia.
  • FDA and EU requirements covering Design Control activities for IVDs and/or medical devices.

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 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

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.



  • Staff QA Specialist

    2 months ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Danaher Full time

    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...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom AtkinsRéalis Full time

    Job DescriptionWelcome to AtkinsRéalis You might know us for the great work we do across our huge variety of projects. It's all thanks to our people's combined diversity of thought, expertise and knowledge that we can continue to make a difference worldwide. And when you join us, you'll be a part of this genuinely collaborative environment, where everyone's...

  • Audit Senior

    1 month ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Search & Select Offshore Limited Full time

    Our client seeks an Audit Senior to join their Audit and Assurance team.Role Profile: By joining the Audit and Assurance team you will work closely with audit partners and you will have a real opportunity to provide a valued opinion within the team. Excellent opportunities exist for ambitious and driven candidates to progress within the firm. It is the...

  • Audit Senior

    22 hours ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Search & Select Offshore Limited Full time

    Our client seeks an Audit Senior to join their Audit and Assurance team.Role Profile: By joining the Audit and Assurance team you will work closely with audit partners and you will have a real opportunity to provide a valued opinion within the team. Excellent opportunities exist for ambitious and driven candidates to progress within the firm. It is the...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:Salary: Research Associate:...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:Salary: Research Associate:...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary:Research Associate: £33,966 to £44,263 per annumSenior Research Associate:£45,585 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.Closing Date: 23 June 2024The...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary:Research Associate: £33,966 to £44,263 per annumSenior Research Associate:£45,585 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.Closing Date: 23 June 2024The...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Greggs Plc Full time

    This is a full-time based role on a 12 month fixed term contract, based at Greggs Innovate House, Newcastle upon Tyne, NE12 8EW This is a full-time role, however flexibility in this will be considered We know that having a work-life balance is important, so we offer our colleagues as much flexibility as possible in line with the needs of their role Vacancy...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Greggs Plc Full time

    This is a full-time based role on a 12 month fixed term contract, based at Greggs Innovate House, Newcastle upon Tyne, NE12 8EW This is a full-time role, however flexibility in this will be considered We know that having a work-life balance is important, so we offer our colleagues as much flexibility as possible in line with the needs of their role Vacancy...

  • Head of Operations

    3 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    The Role This is an exciting opportunity to join Newcastle Clinical Trials Unit (NCTU), a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit, as Head of Operations. NCTU is an academic unit, that works in collaboration with investigators to design and conduct high quality trials and studies, bringing substantial impact to patients...

  • Head of Operations

    22 hours ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    The Role This is an exciting opportunity to join Newcastle Clinical Trials Unit (NCTU), a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit, as Head of Operations. NCTU is an academic unit, that works in collaboration with investigators to design and conduct high quality trials and studies, bringing substantial impact to patients...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BBC Full time

    Job BandPackage description Band: D Contract Permanent Salary : £65,000 to £85,000 depending on level of experience Location: Salford, and Newcastle Our comprehensive benefits package includes: An employer pension contribution of up to 10% 26 days' annual leave (based on full time hours) + bank holidays and the option to buy/sell additional days...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BBC Full time

    Job BandPackage description Band: D Contract Permanent Salary : £65,000 to £85,000 depending on level of experience Location: Salford, and Newcastle Our comprehensive benefits package includes: An employer pension contribution of up to 10% 26 days' annual leave (based on full time hours) + bank holidays and the option to buy/sell additional days...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary: £29,605 to £30,487 with progression to £32,982 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.Closing Date: 12 June 2024The RoleThe main purpose of the Tissue...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary: £29,605 to £30,487 with progression to £32,982 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.Closing Date: 12 June 2024The RoleThe main purpose of the Tissue...

  • Director of Faculty

    1 month ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle Sixth Form College Full time

    We are looking for an inspirational and highly successful Director of Faculty to join our Senior Leadership Team. Newcastle Sixth Form College offers an academic A Level curriculum in an inclusive and aspirational environment, where students are supported to go on to exceptional destinations. Over 1300 students choose to study with us, often travelling long...

  • Technical Specialist

    1 month ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:The RoleYou will be part of a...

  • Technical Specialist

    22 hours ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:The RoleYou will be part of a...

  • Audit Senior Manager

    1 month ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom RSM Full time

    As one of the world's largest networks of audit, tax and consulting firms, RSM delivers big ideas and premium service to help middle-market businesses thrive. We are a fast-growing firm with big ambitions -- we have a clear goal to become the premium adviser to the middle market, globally. This vision touches everything we do, motivating and inspiring us to...