Senior Quality Assurance Engineer
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
- 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