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Quality Engineer

Description

Phillips-Medisize A/S is part of the Pharmaceutical and Medical Division of Molex, a leader in the design, development and delivery of advanced drug delivery devices and connected health solutions.

Phillips-Medisize A/S is collaborating with leading pharmaceutical companies worldwide by offering innovative and integrated solutions supported by an end-to-end service from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com.

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

As a Quality Engineer, you will:

  • Promote compliance of the design and development activities and documentation by:
  • Review documentation.
  • Maintain an overview of the project documentation.
  • Support 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:

    • Minimum a Bachelor’s degree in life science or engineering/3 years of 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 detailed oriented approach.
    • Strong organizational skills, and the ability to multi-tasking.
    • Pro-active in identifying potential improvement and proposing lean solutions.
    • Fluency in English, both verbally and in writing.
    • 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 a leading role for project quality.

    #LI-IB1

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