Über Jonathan
À mon sens, seule une démarche qualité alignée sur les contraintes opérationnelles réelles, construite main dans la main avec les fabricants, permet d’assurer une intégration efficace des processus qualité et de bâtir une stratégie durable et efficiente. Je mets mon expertise au service des entreprises souhaitant garantir la conformité réglementaire et l'excellence opérationnelle de leurs produits de santé.
Scientifique de formation, je me suis finalement spécialisé en assurance qualité et règlementaire dans l'industrie du dispositif médical. Mon approche est structurée, pédagogique et orientée résultats. J’aime faire le lien entre les exigences réglementaires et les réalités industrielles afin de construire des systèmes qualité pragmatiques, durables et intégrés.
Französisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher
Deutsch
Konversationssicher
Nur remote
Führt Projekte hauptsächlich remote aus
Projekt- und Berufserfahrung
- IntrasenseQuality ManagerMärz 2024 - Juni 2025 (1 Jahr und 3 Monate)Montpellier, FranceQuality Assurance (system)• Responsible for managing the takeover of the quality management system and compliance with applicable requirements• Monitor QMS activities as planned• Contributing to compliance with new medical regulations• Leading management reviews• Preparing for and taking part in audits (External/internal/supplier)regulatory guidelines and act as an objective reviewer to examine the documents and ensure that product development complies regulatory guidelines.• Review project deliverables, such as design verification and validation reports.• Participate in usability and risk management activities.• Participate in the preparation of the regulatory submission.• Supporting post-marketing activities where necessary, such as corrective and preventive action projects related to identified design issues, assistance with root cause analysis, CAPA preparation, complaints and risk assessment of distributed products.
- IntrasenseSenior AQ EngineerMEDIZINOktober 2022 - März 2024 (1 Jahr und 5 Monate)Montpellier, FranceResponsible for managing the takeover of the quality management system and compliance with applicable requirements• Monitor QMS activities as planned• Contributing to compliance with new medical regulations• Leading management reviews• Preparing for and taking part in audits (External/internal/supplier)regulatory guidelines and act as an objective reviewer to examine the documents and ensure that product development complies regulatory guidelines.• Review project deliverables, such as design verification and validation reports.• Participate in usability and risk management activities.• Participate in the preparation of the regulatory submission.• Supporting post-marketing activities where necessary, such as corrective and preventive action projects related to identified design issues, assistance with root cause analysis, CAPA preparation, complaints and risk assessment of distributed products.
- Int'Air MedicalDeputy Manager Quality AssuranceJanuar 2020 - September 2022 (2 Jahre und 8 Monate)Ain, France• Review, update and improve "Customer Complaint" procedure• Analyze customer complaints• Lead "Customer Complaints" meetings to determine the root cause and shape the action plan• Manage CAPA progress regarding non-compliancies and write CAPA updates• Share to customers the issue causes and implemented corrective actions• Follow-up of Medical Device Vigilance files in association with the QR/RA Manager• Update and analyze quality KPI• Coordinate supplier selection and qualification• Participate to purchase contracts drafting• Draft supplier technical and quality specification and ensure they are respected• Handle changes requested by suppliers• Assess suppliers• Carry supplier audits and monitor their corrective action implementation• Issue supplier non-compliancies and monitor their corrective action implementation• Supervise and coordinate AQ team activities : 6 members• Assist Direction as part of the steering process and into QMS monitoring and surveillance: non-conformities, customer complaints, internal and third parts audits, CAPA, KPI, etc., in collaboration with the QA/RA Manager• Carry internal and external audits
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Ausbildung und Abschlüsse
- FDA regulation 21CFR820 and ISO 13485 Responsable Qualité et affaires réglementaires Dispositifs Médicaux Construire son système de management de la qualité ISO 13485 La gestion des risques pour les dispositifs médicaux selon la normeFDA regulation 21CFR820 and ISO 13485 Responsable Qualité et affaires réglementaires Dispositifs Médicaux Construire son système de management de la qualité ISO 13485 La gestion des risques pour les dispositifs médicaux selon la norme
- Master 2 (M2)Université de Montpellier2018Master 2 (M2)