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Quality Engineer

This job posting is no longer active.

Description

Do you want to play a central role in supporting the organization in its efforts to ensure the development of highly reliable, safe and effective medical devices?

Are you a team player with strong analytical skills, critical thinking and a specific attention to details?

Then you may be the person we are looking for to join our growing team in Phillips-Medisize’s Global Innovation & Development Center based in Virum and Struer.

What You Will Do In Your Role

  • Promote compliance of the design and development activities and documentation by reviewing documentation, maintaining an overview of the project documentation and supporting production and quality control for prototyping.
  • Play a central role by facilitating the interface between project’s team members.
  • Support the design and development team in collaboration with the project manager.
  • Collaborate closely with the regulatory affairs team to ensure documentation required for submission are adequate and available.
  • Be part of technical design reviews and support the change management process.
  • Facilitate the transfer of information from the technology and development team to the manufacturing department for early prototypes, and clinical builds.
  • Support the improvement effort to streamline the quality documentation process.

    The Experience You Will Bring

    Requirements:

    • Bachelor’s degree in life science or engineering or higher education in a technical discipline.
    • Experience in a similar position in design and development, manufacturing, or quality management.
    • Analytical skills, critical thinking and rigor.
    • Pragmatic and detail-oriented approach.
    • Strong organizational skills and the ability to multi-task.
    • Pro-active in identifying potential improvement and proposing Lean solutions.
    • Fluency in English, both spoken and written.
    • Proficiency with MS Office.

    What Will Put You Ahead

    • Experience working in a regulated environment, preferably medical devices.
    • Knowledge of ISO 13485, 21 CFR Part 820, good documentation practices.
    • Experience in generating documentation intended for regulatory submissions.
    • Experience working in project involving multiple disciplines.
    • Experience in assuming leading role for project quality.

    What We Can Offer You:

    • Opportunity to join a growing team working in a fast pace and multidisciplinary environment.
    • Opportunity to be part of medical device development from the concept to the finished product.
    • Work on medical devices intended to be used with drug developed by leading pharmaceutical companies around the world.
    • Mobile Phone
    • Broadband connection at home
    • Private health insurance
    • Competitive pension scheme

    #LI-IS1

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