Boulogne-Billancourt
In charge of design and process validations of medical device class III, incoming and in process controls activities:
- DHF, DMR, QSR 21 CRF Part 820
- ISO 13485
- MDD 93:42
- Risk management files, dFMEA, pFMEA ISO 14971,
- IOPQ,
- Suppliers audit (LNE training) and qualification,
- KOL meetings,
- CAPA, NCRs handlings
- ASTM F1717, ASTM F1798, ISO 12189, ISO 10555,
- Sterilisation Validation ISO 11137, ISO 11737,
- Microbiological validation and follow up,
- Stability studies,
- Team management: 6 QA inspectors,
- Project management,
-...
Mes compétences :
Qualité
