Design Quality Assurance Engineer - Germering - Beckman Coulter - Diagnostics

    Beckman Coulter - Diagnostics
    Beckman Coulter - Diagnostics Germering

    vor 6 Stunden

    Ganztags
    Beschreibung

    Bring more to life.

    Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

    At Beckman Coulter Diagnostics, one of Danaher's 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.

    As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

    The Design Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible for the conformity of the design process with applicable regulation.
    You will be a part of the Quality Assurance team and report to the Quality Assurance Manager responsible for new product development and Design Changes from a QA perspective.
     

    This position is part of the Quality Assurance department located in Großhadern (near in Munich).

    This position is initially offered on a one-year fixed-term contract, with the possibility of extension or transition to a permanent role.


    If you thrive in a fast paced role and want to work to build a world-class quality organization—read on.

    In this role, you will have the opportunity to:

    • Closely engage in R&D projects towards introduction of new products or design changes as quality representative

    • Proactively provide guidance to maintain and improve compliance of development projects with global and local processes

    • Ensure conformity of the design process with applicable regulation

    • Review and approve design and development documentation

    • Develop and execute validation plans and protocols

    • Generate and maintain the risk management files

    • Drive risk assessments

    • Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics

    • Support post-market surveillance activities

    Qualifications:

    • Degree in chemistry, life sciences, engineering or quality management or equivalent education gained through work experiences

    • Work experience or research experience in chemistry, life sciences, engineering or quality management (+2 years)

    • Fluent in English - written and verbal. German is a plus.

    • Computer skills (MS Office products)

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

    • Practical experience of workflows in laboratory environments

    • Experience within the regulated environment of in vitro diagnostics or medical devices

    • Experience in design verification and/or validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment

    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

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