Beschreibung
Projekt Nr.: A3937Funktion CAPA legacy review consultant / ISO 13485 (contract)
Branche Dienstleistungsunternehmen
Pensum 100%
Arbeitsort Bern Ost
Antrittstermin asap
Dauer 6 Monate mit Option
Anzahl Stellen 17
Stellenbeschreibung
https://www.ghrgroup.ch/projekt-details/orderNr/A3937.html
Für unseren Kunden suchen wir mehrere sehr erfahrenen CAPA legacy review consultant / ISO 13485 wie folgt:
Main Responsibilities:
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
Must-Skills:
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
Nice to have:
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
Diverse Tätigkeiten gemäss Projektleiter
Anforderungen
IT Profil Priorität
Capa Management ein Muss
ISO 9001 ein Muss
ISO 13485 ein Muss
Qualitätsmanager ein Muss
Sprachen
Sprache mündlich schriftlich Priorität
Deutsch sehr gut sehr gut ein Muss
Englisch sehr gut sehr gut ein Muss
Wir freuen uns auf Ihre Bewerbung
André van Sprundel
CEO
GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG
Tel:
Direktnr:
Fax:
E-Mail:
Web: http://www.ghrgroup.ch
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