For our partner, a medical devices contract developer with focus on the field of orthopedic implants and instruments, we’re looking for a Quality System Manager. The company provides services in innovation, Research & Development, Operations and act as Legal Manufacturer for over 15 Medical Devices.
As Quality System Manager you will be responsible for the Quality Management System, Document Management System, CAPA’s and internal audits. Besides that, you’ll among others lead continuous improvement projects. In this position you’ll report to the QA/RA Manager.
- You ensure an effective, efficient and user-friendly QMS
- You’ll have an active role in the CAPA process
- Lead continuous improvement projects
- Maintain and improve the document management system
- Facilitate Internal audits and also customer, notified body and FDA audits
- Provide training of colleagues
- Minimum of Bachelor working level
- At least two years’ experience within QA for Medical Devices (ISO13485)
- Knowledge of and experience with submissions under MDD/MDR/FDA is a preference
- Sterke communicator
- Pragmatic, independent, team worker, Quality minded and customer focused
ORGANISATION AND OFER
You’ll join an entrepreneurial, growing, open and informal organisation and will be involved in successful projects with customers all over the world. You’re part of a multi-disciplinary team that is continuously creating value for their clients, medical professionals and patients. Herewith, QA is key within the company.
This is a unique opportunity to develop yourself and to grow within the company. 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 email@example.com