Description
If you like to improve yourself and use your technical skills in a global active and well known company, Real Staffing has the perfect opportunity for you.For a project in the central of Switzerland we are searching for a CAPA Trainer for 6 month, perhaps with extension.
MAIN DUTIES & RESPONSIBILITIES:
* CAPA Trainer, you will teach your colleagues how to handle CAPA processes
* Engage with local CAPA and site process SMEs to ensure adequate review of CAPA content and product and process risk
* Alert management of product quality & compliance issues for proper and timely escalation to CAPA.
KEY COMPETENCIES REQUIRED:
* Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
* Expert knowledge of the US Quality System Regulations and ISO 13485
* Demonstrated track record of delivering best in class results in the Quality Systems area
* Fluent in German and in English - able to review CAPA documents & interact with CAPA & site process SMEs
QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
* 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
* Proven ability to build partnerships both internally and externally
If this outstanding opportunity sounds interesting, do not hesitate to contact me for more details or send me your CV.
For more information on this or other opportunities contact Marco Heumann, at Real Staffing Group, Zürich