CAPA Specialist - Post Market Surveillance (Medical Devices)
My client is a Medical Devices company, specialised in the design, development and manufacturing of custom designed pacakaging for the Medical Devices industry.
The CAPA Specialist will be responsible for the complaints that are coming in from the customers. Different to a normal post market surveillance position, you will deal with complaints of Medical Devices manufacturers. Furthermore, the CAPA specialist will work closely with the QA Engineering team for improvement projects and Quality related activities.
- Handling of complaints from Medical Devices companies
- Daily QA duties (handling of CAPA's, change controls, non-conformities)
- Improvement of the QA System and production to reduce complaints
- SME for the client regarding Quality related to production and complaints
- Maintain and develop the QMS (ISO13485, ISO9001, MDR, ...)
- BSc. / MSc. Pharmacy in Life Sciences / Engineering
- 3+ years of experience with Medical Devices
- Experience with CAPA's and Rootcause analysis
- Knowledge of ISO13485
- Knowledge of MDR is seen as an asset
- Strong communication skills
- Fluent in English, both written and spoken
My client is offering a one year (after the 1st year an undetermined) contract with a good basic salary, topped up with attractive extra benefits (36 Holidays, Pension Plan, reduction on Health Insurance, ...)