Beschreibung
MAIN DUTIES & RESPONSIBILITIES:* Perform Management Review remediation per schedule.
* Access product and process risk and alert management of product quality & compliance issues for proper and timely escalation to CAPA.
* Engage with local Quality Management and site process SMEs to ensure adequate actions are taken.
* Provide support for documentation of remediation activities.
* TO ADHERE TO THE COMPANY'S PROCEDURES AS DETAILED IN THE SOP MANUAL
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
* The ability to independently execute risk assessments and remediation activities
* Fluent in German and in English - able to review CAPA & sub-system data and documents & interact with Quality Management & 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 you feel suitable for this role, I´m looking forwart to receive your online application.
To find out more about Real please visit www.realstaffing.com