Helene BEURTHERET

En résumé

Entreprises

• General Electric Healthcare - REGULATORY AFFAIRS AND QUALITY SPECIALIST

  Paris 2016 - 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

  PARIS 2016 - 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

  Valence 2015 - 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

Formations

• Université Reims Champagne Ardenne-Faculté Des Sciences Exactes Et Naturelles

  Reims 2014 - 2016 Master Biologie santé Qualité
  
  Normes et Règlementaions, Système de Management de la Qualité, Métrologie, Biologie Cellulaire, Biotechnologies appliquées à la Santé.

• Université Lille 1 Sciences Et Technologies

  Villeneuve D'Ascq 2010 - 2014 Licence Biologie Cellulaire et Physiologie
  
  Biologie Cellulaire, Physiologie, Neurologie, Biochimie, Endocrinologie, Biologie Moléculaire, Biotechnologies.