Beschreibung
Capa consultants - CAPA, Quality, QA, Compliance, Risk, ISO, GxP, GMP
The ideal candidare will possess the following attributes
- Excellent experience with Corrective and Prevantative Action (CAPA)
- Excellent communication
- System design and management skills - Organizational and Quality Systems
- Knowledge of the US Quality System Regulations and ISO 13485
- Track record of delivering results in the Quality Systems area
- Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
- Working knowledge of Quality System Regulations.
- A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
- Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
- Demonstrated knowledge of business impact of compliance issues and risk management