Product Quality and Risk Management Specialist
il y a 4 semaines
En tant que membre de l'équipe de Fresenius Medical Care, vous contribuerez à la préparation et à la mise en œuvre de stratégies de qualité et de gestion des risques pour les produits de concentration pour hémodialyse et les désinfectants.
Vous serez chargé de la gestion des dossiers d'analyse de risques produits, en collaboration avec l'organisation globale des réclamations et de la structure globale de matériovigilance.
Vous préparerez les données de surveillance post-marché par groupe de produits, y compris les analyses IMDRF, et coordonnerez la gestion des principaux problèmes qualité produit.
Vous suivrez et élaborerez les rapports d'indicateurs clés de performance de la qualité, et déterminerez le potentiel d'amélioration des processus liés à la qualité en utilisant des méthodologies et des outils spécifiques.
Profil
Vous avez un bac+5 (ingénieur, master...) avec une expérience de 5 ans dans le domaine des affaires réglementaires ou de la qualité (secteur pharmaceutique/médical).
Vous possédez des connaissances approfondies de la réglementation des dispositifs médicaux (réglementation NMPA, MDD 93/42/EEC, MDR 2017/745, MDSAP, etc.) et des normes applicables (ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.).
Vous connaissez la méthodologie CAPA et le traitement des réclamations ainsi que les méthodes statistiques.
Compétences requises
• Connaissances approfondies de la réglementation des dispositifs médicaux
• Expérience dans le domaine des affaires réglementaires ou de la qualité
• Connaissances de la méthodologie CAPA et du traitement des réclamations
• Connaissances des méthodes statistiques
Avantages
• Travailler dans un environnement dynamique et innovant
• Contribuer à la préparation et à la mise en œuvre de stratégies de qualité et de gestion des risques
• Développer vos compétences et votre expertise dans le domaine de la qualité et des risques
Comment postuler
Si vous êtes intéressé par cette opportunité, veuillez envoyer votre candidature, y compris votre CV et une lettre de motivation, à l'adresse suivante: [adresse email ou lien vers le site de recrutement]
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