Our client is a leading contract developer and manufacturer, producing quality medical and pharmaceutical components, as well as finished devices. With offices in a Europe, Scandinavia and the USA, they are a growing organisation and in need of a Senior Quality Engineer to bolster the Dutch operations, taking responsibility for maintenance and continuous improvement of the plant quality system.
- - Generate, review and authorize Quality related documents
- - Lead and/or participate in (quality improvement) projects
- - Maintain the CAPA (corrective and preventive actions) system
- - Develop and conduct Quality and Quality improvement trainings for NL employees
- - Execute and follow up internal and external audits
- - Release products, processes and equipment
Typically this person will be degree qualified to Bachelor level with solid experience in QA within the Medical Devices sector or similar over a number of years including maintaining and improving Quality management systems to ISO 13485. FDA 21CFR820, MDD 93/42EEC or similar. QA experience should be within production level and preferably include EO sterilization, and also Cleanrooms and microbiology exposure. Participation or leading of Audits to ISO 13485 is essential, as are both English and Dutch language skills.
For more information on this exciting opportunity, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at firstname.lastname@example.org
Posted: 11/08/2012 | NPJ Ref: 84896