Leica Biosystems

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. 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 . 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.

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. 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 . 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.

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 Senior Scientist Investigations for Leica Biosystems is a source of technical expertise and support, responsible for supporting LBS in the timely assessment and implementation of post-launch changes and product concerns, arising from areas such as customer complaints, and internal product surveillance. This position is part of the Technical Operations Department located in Newcastle, UK and will be an onsite roll. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives. You will be a part of the Investigations Team and report to Technical Operations Leadership responsible for providing technical support and expertise for on market IVD Medical Devices . If you thrive in a science driven and data driven, faced paced, multifunctional role and want to work to build a world-class Life Science organization-read on. In this role, you will have the opportunity to: Provide technical expertise for supporting on market products and post release changes with an emphasis on providing technical expertise and support for on market In-Vitro Diagnostic (IVD) Lead well defined project/work packages in functional areas to continually improve products and services. Coach and mentor a small team as required and support others to solve complex problems. Take a scientific and data driven approach to continually improve market leading Advanced Immunohistochemical Assays Continually develop within a market leading, global organization The essential requirements of the job include: Previous Experience of working with, or developing IVD, ideally in relation to FISH and ISH Advanced Immunohistochemical Assays. Knowledge of the Molecular Chemistries involved in Advanced Immunohistochemical Assays Experience of Microscopic slide examination and interpretation of antibody/probe staining Proven and demonstrable experience in problem-solving and troubleshooting Proven and demonstrable experience in writing scientific documents, plans and reports Working within a highly regulated environment Travel, Motor Vehicle Record & Physical/Environment Requirements: Travel expectations for this role are Low ( 10%) It would be a plus if you also possess previous experience in: Recombinant Protein Manufacture Hybridoma Growth and Cell Culture Working Knowledge of ELISA 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 . 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.

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. 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.

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. 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 . 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.

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. 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 . 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.

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. 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 . 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.

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. 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 . 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.

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. 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 . 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.

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. 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 . 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.

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. 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 . 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.

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. 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 . 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.