South Holland, Medical Devices, fulltime
Are you looking for a modelling job in a world leading healthcare provider? Do you want to get the opportunity to make a difference in people's live? And at the same time the company will invest in your professional development? Here is the perfect function for you!
For one of my key-clients I'm urgently looking for a QA Manager. You will ensures the company compliance with MDR and you will work closely with the management, subsidiaries and other sales channels.
In this great opportunity you will be responsible for:
- Maintaining managing and improving the company's group ISO 13485/9001 certified quality management system.
- Own and manage this QMS database.
- Manage and take the responsibility for the certified body audits and internal audits. As in, evaluating, defining and monitoring the implementation of the necessary actions.
- Manage the Quality Management System required activities (such as management review meetings, quality objectives, status overviews for management and other staff
- Regularly collaborate with the company's global headquarters on QA and RA; and implement relevant processes.
- Bachelor degree in a relevant field
- 3+ years of work experience in the role of quality engineer or qa manager in the medical device or pharma industry
- Strong knowledge of ISO 13485 and ISO 9001
- Knowledge of ISO 14001, OHAS 18001 and ISO 27001
- Strong knowledge of the EU Medical Device Directive and other regulations, standards (e.g. IEC 90901-1 series) and guidelines applicable on medical devices
- Strong knowledge of and experience with risk management
- Fluent in English written as well as verbal
Could this be the next step in your career? Send your most up-to-date CV to Real Life Sciences or call +31 (0)20 522 1588 and ask for Anneloes Frese. If you would like to ask me additional questions, feel free to contact me! (+ 31 (0)20 522 1588 or a.frese"realstaffing.com).