Senior CAPA Manager Medical Devices (m/f)

-Provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant Medical Device Regulations
-Assist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination
-Maintain overall management and effectiveness of the CAPA system including the process and application for the site.
-Demonstrated leadership ability
-Team building and development capabilities
-Expert knowledge of the US Quality System Regulations and ISO 13485
-Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
-Working knowledge of Quality System Regulations.
-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

Weitere Qualifikationen: Auditor, Quality manager