The company is a pioneer and developer of solutions for controlled bone healing. Their refining technologies are game changing in the field and they’re on a mission to improve patient rehabilitation. This all plus manufacturing takes place in a vibrant location in the Utrecht area.
In this role you’ll be involved in various QA activities like building the QMS, implementation of new processes, Auditing and Validation.
- Process changes, related risk assessments and implementation of process controls
- Design and development projects for new products
- Process validations and Equipment qualification
- Implementation and SW validation of QA/QMS
- Qualification of Suppliers, co-developers and distributor
- Training of employees, Audits, Complaint investigations, Batch records, CAPA handling
- Educational degree: Bachelor or equivalent
- 4+ years of experience in relevant QA domains in ISO 13485 or 9001 certified environments
- Auditing experience is a must and validation experience is preferred
- Excellent English communicatio
- Accurate, pro-active, analytical, and strong communication skills
ORGANISATION AND OFFER
This is an entrepreneurial company and still acting as a start-up. At the same time, they are for more than 20 years, specialised in high-risk medical devices. They’ve 140 years of combined research experience amongst the team and refining technologies that are game changing in the field. This organisation is unique in what they do, with more than 80 (pending) patents.
The organisation offers an attractive salary and generous conditions.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org