Beschreibung
The responsibilities of this position include:
Support for CAPA process on site Zuchwil, Selzach, Bettlach, Grenchen, Oberdorf, Waldenburg, Hagendorf. 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 non conformance's 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
further the following would present a considerable advantage:
Experience in Six Sigma. Black Belt or Green Belt
Technical education. Preferred engineering degree