Senior Quality Assurance Engineer, Post-Market Complaints Handling EMEA
il y a 2 semaines
Poste : Ingénieur Qualité Senior, Traitement des Réclamations Post-Marché EMEA
ResMed recherche un Ingénieur Qualité Senior pour rejoindre son équipe Qualité et Affaires Réglementaires à Saint-Priest.
Responsabilités :
- Identifier, évaluer et capturer les réclamations relatives aux produits mis sur le marché et distribués par ResMed pour la région EMEA, en accord avec les procédures qualités ResMed et les exigences réglementaires applicables.
- Travailler avec l'ensemble du personnel de ResMed pour s'assurer que les informations relatives aux réclamations sont enregistrées dans le système IT de traitement des réclamations en accord avec les procédures locales.
- Rédiger et assurer la relecture des communications et des rapports (y compris les réponses aux clients) concernant les problèmes de qualité qui affectent les clients sur la région EMEA.
- Être le point de contact Régional pour la mise en place de solutions définies par les équipes Globales pour l'identification et la remontée de réclamations produits spécifiques.
- Assurer la collecte des données requises pour le traitement des réclamations, en particulier pour les cas de vigilances et pour toutes demandes spécifiques en provenance d'une autorité externes (ex : autorités compétentes, police,...).
- Assurer les formations de toutes personnes impliquées dans la gestion des réclamations en EMEA.
- Participer à l'amélioration continue du traitement des réclamations, de la conformité réglementaire, des bonnes pratiques de l'industrie, de la qualité des produits et de l'efficacité interne. Participer à des groupes de travail avec des entités externes à ResMed si nécessaire.
- Apporter son support pour les audits, le traitement des CAPA (actions correctives et préventives), et des actions correctives sur le terrain pour les produits ResMed et distribués par ResMed.
Qualifications et Expérience :
- Maîtrise de l'anglais à l'écrit et à l'oral (échanges à l'international réguliers).
- Connaissance des exigences réglementaires et standards qualités applicables aux dispositifs médicaux (MDR 2017/745 – ISO 13485).
- Minimum 5 ans d'expérience dans l'industrie des dispositifs médicaux ou de l'industrie pharmaceutique.
- Diplôme de formation supérieure (Ingénieur ou équivalent) dans le domaine des industries de la santé ou équivalent.
Qualités personnelles :
- Excellent relationnel.
- Dynamique.
- Rigoureux.
- Solides compétences organisationnelles et esprit proactif.
- Capacité à travailler dans des délais serrés.
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