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Valerie DUBOIS

Boulogne-Billancourt

En résumé

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

Entreprises

  • St. Jude Medical - Quality Manager

    Boulogne-Billancourt 2013 - maintenant
  • Endosense - Sr Quality Engineer

    2010 - 2012
  • SpineVision - Industrialisation & R&D project manager

    Lyon 2004 - 2010 Optimisation spinal implants (C3, Uni Thread)
    Design Transfert (Uni Thread, LUMIS, FlexPlus)
  • SYMBIOS - Ingénieur Process

    2003 - 2004 Design Transfert de la SPS Modulaire - prothèse de hanche à col modulaire

Formations

Réseau

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