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Senior Quality Assurance Engineer

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-MS3

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