Mes compétences :
Microsoft Office
Norme ISO 9001
Normes ISO 13485
Norme ISO 14001
GMP
MDD
QUALITY MANAGEMENT SYSTEM
MDR
Entreprises
General Electric Healthcare
- REGULATORY AFFAIRS AND QUALITY SPECIALIST
Paris2016 - maintenant• Product registration in Italy and Israel for all GE Healthcare products
• Prepare and send investigation reports for field corrective actions, post-market surveillance and mandatory report events to the European Authorities
• Evaluate incidents and corrective actions following customer feedback and answer inquiries from European Competent Authorities
• Perform investigation reviews and risk assessments
Arcancil Paris
- QUALITY & REGULATORY AFFAIRS INTERSHIP
PARIS2016 - 2016• Drafted quality assurance processes and provided team training for their implementation
• Assessed the quality of incoming components for production of finish goods via AQL standards and limits by performing aesthetic and functional inspection and set the standards for production expectations
• Facilitated all sample submissions to laboratories for stability, package compatibility, safety and claims testing and assisted in gathering all necessary technical data and documentation for product registration
• Assisted supplier audits in Italy
Biomet Zimmer
- QUALITY ASSURANCE INTERNSHIP
Valence2015 - 2015• Revised internal “Non-Conformance Control Process”, which included:
- Anticipation of the requirements of the new version of ISO 13485
- Simplification of input-outputs to ensure the treatment of non-conformance within 21 days.
- Drafting of the Internal non-conformance handling process and creating the form: “Internal NC Report”
- Development of a classification of internal non-conformance
• Handled internal non-conformance and customer complaints
• Revised the “Supplier Management Process”: anticipation of the requirements of the new version of ISO 13485 and creation and modification of several forms