- Fastgrowing international medical device company
- Hybrid role / make a difference within the world medical aesthetics
Over onze klant
An international medical device company specialized within the Medical Aesthetics. They are rappidly growing their organization worldwide.
You will be releasing/ qualifying products, intermediates, processes & equipment. You will also take part of the QMS development and maintenance to selected standards/ regulations. Trend data resulting from processes owned by QA department and report outcome. Review trend data from other departments.
Support the QA Manager with the following processes: Supplier Quality Management, Management Review, Design and process changes, Complaint handling/ Vigilance, Audits by Notified Body or third parties, CAPAs, Batch release and Receiving Inspection (raw materials, intermediate and final products), Handling of Non-Conformity (deviations), Out of Specification, Internal Audits, Investigations of product complaints
Initiating / Implementation of improvement projects. Assessing Production activities, Production and QC tests for correct functionality. Initiating and chairing meetings related to Quality and Production activities. Approve documents, e.g. validation protocols and reports, investigation protocols and reports.
- At least a Bachelors' or equivalent
- Experience within Quality in the medical device, pharma, biotech or cosmetic industry.
- Knowledge of ISO 13485, MDSAP, MDR and GxP regulations.
- You are proactive - you identify opportunities and maximise them; you identify issues and you look to head them off
- You value autonomy - you seek management steering, but have the confidence to make decisions
- Experience with aseptic filing of syringes
- Experience with sterilization (EtO, Gamma, Steam)
- A good salary
- 13th month
- 25 vacation days
- 8% holiday pay
- Travel allowance at €0,19 per kilometre
- Retirement savings plan