Gael BATAN

En résumé

Entreprises

• Agfa - QARA Manager

  maintenant

• Agfa HealthCare - Software Project Manager & QARA Manager

  Artigues près Bordeaux 2009 - maintenant ACHIEVEMENTS
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  • Integration of Shanghai R&D teams with company global processes and tools.
  • Shanghai R&D site (55 people) ISO13485 certification and follow up.
  • Shanghai R&D site CAPA Management
  • Contribution to company global QARA framework and QMS implementation (8 R&D sites over 7 countries worldwide)
  • Regulatory compliance and Technical files preparation for Software Medical Devices registration (FDA, CE mark, CMDCAS).
  • ISO13485 – ISO9001 - Cross site internal audit - Software Design control,
  • R&D Teams Management: 2 teams, over 10 Chinese people (hiring, retention, performance review, personal development).
  • R&D Projects Management: worldwide cross site software development coordination (China/Canada/US/Belgium) on 3 parallel projects
  • Supervision of software test environment setup and testing strategy definition
  • Implementation of Agile SCRUM software development processes and promotion of Test Driven Development and automated testing.
  • Promoter of Automated Design Control and cross site communication improvement (wiki oriented).
  
  
  EXPERTISE
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  • Agile processes – SCRUM
  • Internal Auditing: ISO 13485 – ISO 62304
  • Software Design Control
  • Testing strategy (Smoke, Functional, Regression, Performances … manual and automated testing)
  • Leadership development
  • Product Management (requirements management) – Client/Server & Web Applications

Formations

• Université Compiègne master MTS

  Compiegne 2005 - 2006

• Université Toulouse 3 Paul Sabatier

  Toulouse 2001 - 2004

Réseau

• Alexandre THOMAS

• Anne Charlotte MILLABET

• Benoit AUBIN

• David BLEUZET

• David CREDOZ

• Georges GUENNOC MOREL

• José INIGO

• Matilde MATELLICANI

• Romagny PATRICK