Beschreibung
Task:Provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant with company standards and Medical Device Regulations.
Responsibilities:
* Support the implementation of the standardized procedures, processes and systems for CAPA
* Deliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA content
* Maintain overall management and effectiveness of the CAPA system including the process and application for the site.
* Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes.
* Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA.
* Provide CAPA compliance metrics and weekly management tracking report.
* Facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems
* Liaise with the EU CAPA Manager to align on system requirements to support the CAPA process
Requirements:
* Fluent in German and English
* System design and management skills - Organizational and Quality Systems
* Expert knowledge of the US Quality System Regulations and ISO 13485
* Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
* 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
If you are suitable for this project please send your CV to Marcus Müller.
You can also call me on for further information.
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com