Mes compétences :
Gestion de projet
Assurance qualité
Marquage CE
Immunoessai
FDA
Entreprises
BioMérieux
- Product Development Project Manager
MARCY-L'ETOILE2008 - maintenantManage cross-functional teams to deliver new products within defined business requirements of cost, quality and time. Manage financial indicators (NPV, IRR, payback). Guarantee design control in accordance with applicable regulations and company policies and procedures (ISO 13 485, QSR Part 820...). Manage project and product risks and monitor the implementation of solution and mitigation plan to reduce risks. Communicate project progress to project team and to Executive Committee.
International projects with USA and China sites.
Achievement: Development of 3 complete immunoassay diagnostic reagents for use on instruments (VIDAS®): budget 2-4M EUR , FDA approved. Achievement of 3 projects of products improvements (bioNexia® and VIKIA®). Development of a Service offer for customer (package including software, guide and coaching).
BioMérieux
- R&D Quality Engineer
MARCY-L'ETOILE2006 - 2008Provide the necessary support and coaching in Design Control and Quality Assurance to complement execution of R&D project development activities.
Work in various fields of in vitro diagnostics: system, software, reagents.
BioMérieux
- Quality Assurance Internship
MARCY-L'ETOILE2006 - 2006Implementation of risks analysis for a reagents range for CE marking, training.
Sanofi Pasteur
- Quality Control Internship
Lyon2005 - 2005Creation of a MS Access Database for laboratory equipment control, implementation of related procedure, implementation of equipment traceability.
