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Brønshøj

    Senior QA Specialist - Bronshoj, Danmark - Danaher

    Danaher
    Danaher Bronshoj, Danmark

    for 1 dag siden

    Danaher background
    Fuldtid
    Beskrivelse

    In our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating impactful innovations like ours, doesn't happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

    Radiometer 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 QA Specialist for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms. This is done by cooperating, supporting, facilitating, training, and communicating towards the best results with partners in R&D.

    This position is part of the QA Design Control department, hybrid based and located in Brønshøj. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

    You will be a part of the QA Design Control team for Blood Gas and report to the Senior Manager QA responsible for QA Design Control with Blood Gas development, developing blood gas analyzers and associated medical devices. If you thrive in an exciting and challenging role putting your experience into play and want to work to build world-class devices with a world class QA organization—read on.

    In this role, you will have the opportunity to:

    • Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
    • Represent Quality Assurance and contribute in innovation, design and development projects and in cross-functional teams supporting new product development.
    • Collaborate closely with R&D, Operations, RA, and other functions to assure high quality throughout the development process including design transfer and post launch activities.
    • Take part in the Quality Assurance activities as an active member of relevant project teams.
    • Participate in quality training activities.
    • Keep updated knowledge of standards, regulatory requirements applicable for Medical Devices/IVD and be involved in driving improvement projects to update relevant parts of the Quality Management System.

    The essential requirements of the job include:

    • The ideal candidate holds a master's degree in engineering or biochemistry (or other educations relevant for QA), with strength in product design processes. However, if the candidate can learn technical aspects fast and communicate in a technical organization, other education at university level relevant for QA work could be accepted.
    • QA specialist with Design Control, Product Quality Engineer or similar vast and solid experience from the medical device or IVD industry or other similar regulated industries.
    • In-depth knowledge of and experience with working according to relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA US 21CFR820, ISO13485, MDD/MDR EU 2017/745, IVDR and MDSAP).
    • Fluent in English writing and speaking.

    It would be a plus if you also possess:

    • Knowledge on Blood Gas Analyzers and accessories
    • Experience with design control processes in one or more of the following areas: Risk management, usability, requirement management, systems engineering and architecture, design verification and design validation.
    • Experience with clinical studies carried out according to IVDR/MDR regulations.

    At Radiometer 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 Radiometer 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.

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