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Experiences

Current Experience

  • QA/RA Manager Medical Devices
    Since June 2015

Past Experience

  • QA/RA Specialist
    May 2015 --- June 2015
    Temporary Mission for class I & IIa MD registration in Australia

  • QA QC Manager Medical Devices
    August 2013 --- September 2014

  • QHSE Manager
    November 2008 --- January 2013

  • QA Manager Medical Devices
    January 2006 --- January 2008

  • Consultant
    January 2004 --- September 2007

Personality

Self Assessment :
IndependenceOptimismInterest in knowledgeProblem solvingResponsibility

Knowledge

Self Assessment :
Aseptic ProcessingAuditingBPFCAPARegulatory submissionsQuality Management System (QMS)Quality ManagementQuality Assurance (QA)Medical DevicesLife Sciences
LinkedIn Assessment :
Quality AssuranceQuality ManagementISO 14001Continuous ImprovementQuality AuditingQuality ControlProject ManagementmanagementinspectionEngineeringProcess EngineeringQuality SystemChange ManagementRisk AssessmentInternal AuditProcess improvementProject EngineeringTeam LeadershipSafety Management SystemsMedical DevicesRoot Cause AnalysisISO 9000Regulatory affairsEnvironmental Management SystemsGMPISO 13485ISOCE markingManufacturingEnglishFailure Mode and Effect Analysis (FMEA)FDABiotechnologyMicrosoft OfficeTrainingCAPAPRINCE2Pharmaceutical IndustryLife SciencesProject PlanningSOPAuditingTeam ManagementStrategy

Skills and Expertise

Self Assessment :
Interact with physiciansCoordinate projectsImplement Quality Management System (QMS)Implement Processes

Education

  • in QA from CQHN - Forem in 0

Training and Certification

  • Auditor QHSE Certification
  • ETO Sterilization Validation Certification
  • PRINCE2 Certification
  • Safety for Operational Supervisors SCC Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency

Area / Region

Chastre-Villeroux-Blanmont, Belgium

Others

Driving License
  • Yes