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Summary

bio-Engineer specialized in Quality Assurance, Quality Management, Clinical and Technical Support, with more than 5 years experience in Life Sciences sector (Medical Devices, Pharmaceutical, ...).

my mission: assist / help / providing counsel & expertise to organizations in their activities.

main strengths:

• strong academic background, double competencies (scientific and Project Management),

• multidisciplinary experience in engineering, Research, Consulting and management,

• multi-sectorial international experience, on various innovative topical projects,

• polyglot - ability to work, live and travel abroad as necessary.

area of expertise: • Quality Assurance, Quality Management and Compliance, • Clinical and Technical Support in Medical Devices sector, • Project Management, Risk Management and Process Engineering, • continuous improvement. recent trainings: cardiac rhythm management – bradycardia master course ISO 13485 – quality and complaint management Clinical support and technical aspect in Medical Devices Project Management and Risk Management complaint / deviations management • lean Six Sigma : yellow belt. • nederlands (dutch - level 2 on going)

Experiences

Current Experience

  • Clinical Technical Support Engineer


    Since May 2015
    livanova plc (merger between cyberonics inc. and sorin group) is a Medical Device manufacturer, developing devices used for cardiac Surgery, neuromodulation and cardiac rhythm management. my missions: providing Clinical and Technical Support related to vns therapy (neuromodulation) and crm (cardiac rhythm management), especially in customer experience and technical expertise. - providing Clinical and Technical Support related to the Medical Device products (vns therapy and crm), especially in customer experience and technical/scientific support, - complaint investigations in accordance with company Policy, FDA and international regulations, - Troubleshooting of events with customers and/or commercial teams, - researches solutions to questions or problems (eg. therapy system questions, product issues) and provides answers according to labelling, specifications and Clinical or technical data, - Training and maintains current knowledge regarding the therapy programs, products and services, - provides technical expertise and knowledge in workshops, product demonstrations and during implant surgeries. skills: Medical Devices, Healthcare sector, technical and Clinical support, cGMP, Compliance, complaint management, Medical Device reporting to the authorities, customer orientation and experience, team player, cardiac and vagal nerve therapy technology. LivaNova PLC (Merger between Cyberonics Inc. and Sorin Group) is a medical device manufacturer, developing devices used for cardiac surgery, Neuromodulation and cardiac rhythm management. My missions: Providing clinical and technical support related to VNS Therapy (Neuromodulation) and CRM (Cardiac Rhythm Management), especially in customer experience and technical expertise. - Providing clinical and technical support related to the medical device products (VNS Therapy and CRM), especially in customer experience and technical/scientific support, - Complaint investigations in accordance with Company policy, FDA and international regulations, - Troubleshooting of events with customers and/or commercial teams, - Researches solutions to questions or problems (eg. Therapy system questions, product issues) and provides answers according to labelling, specifications and clinical or technical data, - Training and maintains current knowledge regarding the Therapy programs, products and services, - Provides technical expertise and knowledge in workshops, product demonstrations and during implant surgeries. SKILLS: Medical devices, Healthcare sector, Technical and clinical support, cGMP, Compliance, Complaint management, Medical device reporting to the authorities, Customer orientation and experience, Team Player, Cardiac and Vagal nerve Therapy technology.

  • Clinical Technical Support Associate


    Since August 2013
    cyberonics, inc. is the Leader in device solutions for epilepsy and is committed to consistently delivering innovative and effective solutions for physicians, caregivers and people with epilepsy. cyberonics’ vns therapy® is the only FDA-approved device for the Treatment of refractory epilepsy. my missions: providing Clinical and Technical Support related to vns therapy, especially in customer experience and Technical Support. Cyberonics, Inc. is the leader in device solutions for epilepsy and is committed to consistently delivering innovative and effective solutions for physicians, caregivers and people with epilepsy. Cyberonics’ VNS Therapy® is the only FDA-approved device for the treatment of refractory epilepsy. My missions: Providing clinical and technical support related to VNS Therapy, especially in customer experience and technical support.

Past Experience

Personality

Self Assessment :
AdaptabilityAnalytical thinkingWillingness to compromiseService orientedSelf-disciplineTrustSociabilityResponsibilityReaction to stressProblem solvingProactivityOrganizationInterest in knowledgeFlexibilityCuriosityCritical thinkingCoordinationCommunicativeCollaborationStrategic thinkingResult OrientedOptimism

Knowledge

LinkedIn Assessment :
Assurance qualitProject ManagementSecteur pharmaceutiquegestion de projetMicrosoft OfficeCAPAQuality AssuranceStrategic PlanningChange ManagementPharmaceutical IndustryCommunicationBidding ProcessProcess EngineeringMicrosoft ExcelFood IndustryMicrosoft WordCAPAsDeviation ManagementPharmaceutical MicrobiologycGMP practicescGMP manufacturingHACCPFood Safety Management SystemEnzyme TechnologyRisk Management PlansFood MicrobiologyPharmaceutical ConsultingFDA GMPQuality System Compliance21 CFREmployee TrainingFrenchEnglishMedical DevicesPacemakersCardiac Rhythm Management

Skills and Expertise

Self Assessment :
Analytical skills Assure medical quality Create SOPs Interact with physicians Write papersAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAnalyze data/information to determine potential relationships.Aseptic techniquesAssure medical qualityCapture data on source documentscollaborate in research projects at universitiesCollect patient forms and questionnairesCommunicate with investigatorComplete case report form (CRF)Conduct limited data and/or statistical analysis.Conduct research at universitiesCreate standard operating procedure (SOP)Data codingDesign data reporting systemsAnalyze proteinDetermine potential relationshipsDocument employees training requirementsFollow up training programsFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesIdentify risksImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Interact with regulatory stakeholdersLabeling compliance with local regulationsMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationOral presentationPrepare internal auditsProvide technical supportQuality control processRegulatory documentationReport deaths to regulatory authoritiesReport non-compliance incidentsReport serious adverse events (SAE)Report technical problemsReview clinical study reportsReview manufacturing documentationReview quality control activitiesSolve problemsTeachingUse laboratory techniquesVerify dataWork under specific instructionsWrite documentsWritten presentation

Education

  • Master (M.Sc.) in Sciences, Technology and Health in Quality Management & Financial Control. from AgroSup Dijon in 2010
  • Master (M.Sc.) in Sciences, Technology and Health in Biotechnology - Microbiological Process & Quality from ENSBANA Engineering School - France in 2009
  • Engineer in Quality Control and Analysis in Biology/Biological Sciences, General from University of Sciences and Technology of Algiers (USTHB) - Algeria in 2008

Training and Certification

  • Test of English for International Communication - TOEIC in 2010 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
French
Full Proficiency
Dutch
Elementary Proficiency
Kinyarwanda
Native

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Engineer Field Service Engineer Senior Scientist Scientist Scientific consultant scientific collaborator Quality Engineer QA Officer QA Engineer QA Consultant Project Engineer Product Specialist Process Engineer Junior Scientist GMP Coordinator Field Clinical Engineer Equipment Engineer
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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