Beschreibung
CAPA (Corrective & Preventative Action) Consultant - German Speaking - Solothurn, Switzerland
Required skills -
- industrial practice in CAPA process in medical devices especially Trauma, Spine and Powertools
- knowledge of regulation and standards like ISO 13485, 21 CFR 820
- German speaking
- extensive FDA experience further the following would present a considerable advantage:
- experience in Six Sigma (Black Belt/Green Belt)
- technical education (engineering degree)
Responsibilities -
- Support for CAPA process on site.
In order to specify: support the owners and the site CAPA Coordinator team for
-appropriate Investigation and Root Cause Analysis,
-definition of appropriate actions (corrections, corrective actions, preventive actions) with including
-the required documentation according to regulation 21 CFR .
The CAPAs deals with design and manufacturing mainly regarding the Quality system.