Beschreibung
CAPA Legacy Review - 6 Months - ASAP - 100% client basedJOB PURPOSE:
Perform NC Legacy Reviews per protocol to ensure adequate review of NC product and process risk
MAIN DUTIES & RESPONSIBILITIES:
* Perform NC Legacy Reviews per protocol per schedule.
* Engage with local NC and site process SMEs to ensure adequate review of NC product and process risk
* Alert management of product quality & compliance issues for proper and timely escalation to CAPA.
* 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
* Fluent in German and in English - able to review NC documents & interact with NC & site process SMEs
QUALIFICATIONS & EXPERIENCE
* 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 interested in this position, I´m looking forwart to hearing from you.
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com