Beschreibung
CAPA Consultant - Senior
This is a contract role. German and English is a must.
QUALITY and COMPLIANCE and AUDIT CONSULTANT
Support for Internal Audit/CAPA processes across EU sites. Potentially requires travel to each site in order to conduct failure investigations and develop robust action plans to remediate Legacy internal audit files. Files pertain to non-conformances regarding Quality systems, design and manufacturing.
Will need to collaborate with team and with SMEs at each site to identify, address, and escalate any issues potentially leading to product or patient risk. Candidate must work both individually and in a team setting and have good written and oral communication skills.
What we require from the candidate:
- industrial practice in Internal Audit and CAPA process in medical device or pharmaceutical industry
- knowledge of regulation and standards like ISO 13485, 21 CFR 820
- German speaking
further the following would present a considerable advantage:
- experience in Six Sigma (Black Belt/Green Belt)
- technical education (engineering degree)