Beschreibung
CAPA Consultant required to 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 nonconformances regarding Quality systems, design and manufacturing.
What we require from the candidate:
- Industrial practice in CAPA process in medical device or pharmaceutical industry
- Knowledge of regulation and standards like ISO 13485, 21 CFR 820
- German speaking essential
Further the following would present a considerable advantage:
- Experience in Six Sigma (Black Belt/Green Belt)
- Technical education (engineering degree)