Support within CAPA (Legacy Review) - Medizin/Healthcare ( 11S-72490)

Vertragsart:
keine Angabe
Start:
10.2013
Dauer:
3 Monate
Ort:
Baden-Württemberg
Eingestellt:
09.09.2013
Land:
flag_no Deutschland
Ansprechpartner:
Nicole Schütze
Projekt-ID:
596086

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Task:
- perform CAPA Legacy Reviews per protocol per schedule
- 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.
- TO ADHERE TO THE COMPANY?S PROCEDURES AS DETAILED IN THE SOP MANUAL

Requirements (Must have):
- 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
- 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

Beginn:
Dauer:
Branche: Medizin/Healthcare