For a dynamic medical device organisation, I am currently looking for a QA Director. In this role you are dedicated to quality by providing customer satisfaction and product safety. Furthermore, you maintain and optimise the QMS, to assure compliance to the relevant standards.
- Maintain and optimise the Quality Management System;
- Assure compliance with applicable rules and regulations (ISO 13485, relevant FDA);
- As part of the Management team, be engaged to maintain alignment and support for Quality activities
- Revise procedures timely and accurately to inspect and report quality issues;
- Successfully coordinates and executes (customer or third party) audits;
- Strong background in QA and RA for Medical Devices;
- In-depth knowledge of ISO 13485, MDR, FDA and experience to maintain contact with relevant authorities as Notified Bodies;
- You demonstrate ownership, keep commitments, and have a positive attitude in a changing environment;
- Growth stimulator, solution-minded, optimistic, open and honest;
- Excellent communication in Dutch and English.
ORGANISATION AND OFFER
This organisation is specialised in high-risk medical devices. A trusted partner in their solutions worldwide. The organisation is game-changing in their field and have ambitious goals for the coming years. Next to a unique opportunity, the company offers an attractive salary, generous conditions and a hard-working and informal culture.
For further information, please contact Christian Steenkamp at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org