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
- 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.