Beschreibung
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)
German and English a must