I’m currently looking for a QA Manager for a dynamic Medical Devices organisation in the Eindhoven area. This company is developing a wearable and multifunctional technology that improves the quality of life. With their device they’ll have a meaningful impact on the healthcare system and they’re aiming to expand the portfolio over the next years.
As QA Manager you’ll have a leading role in maintaining and improving the QMS, ensure MDR compliance and obtain CE Certification for their medical device. Besides that, you’ll oversee the processes throughout the company and maintain relations with stakeholders. This position is for 32 to 40 hours per week.
- Maintain, review and improve the QMS compliant with the ISO13485
- Make sure to set out the timeline, direction and required steps to obtain CE Marking
- Oversee the CE process for the product line
- Work together with regulatory consultants to ensure compliancy with the MDR
- Train the team and keep them updated with the changes in the field
- Maintain and increase the quality awareness within the company
- At least a Bachelor’s or Master’s degree in a relevant area
- Experience with the QMS for Medical Devices (ISO13485)
- Experience with MDD/MDR/FDA and CE Marking experience is a plus
- Strong communicator with active stance
- Analytical, Pragmatic, Eye for detail, Independent and Quality minded
ORGANISATION AND OFER
You’ll join a young and innovative company that believes they will have a meaningful social and financial impact on the current problems within our healthcare system. You’ll be part of an exciting, open work environment where new challenges are faced every day.
You’ll get the opportunity to improve patient care and deliver high-quality products. At the same time, they offer opportunities for personal and professional growth and development. You can expect an attractive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org