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Product Quality and Risk Management Specialist
il y a 1 mois
En tant que leader mondial de la santé, Fresenius Medical Care offre des produits et services pour les maladies rénales et les hôpitaux. Notre site à L'Arbresle est un exemple de notre engagement envers la qualité et la sécurité des patients. Nous recherchons un spécialiste en qualité et gestion des risques pour rejoindre notre équipe de Design Control & Product Center Concentrates & Disinfectants.
Vos principales activités seront :
Gérer les dossiers d'analyse de risques produit pour les groupes de produits concernés
Collaborer avec l'organisation globale des réclamations et de la structure globale de matériovigilance pour l'échange et l'analyse des données
Préparer les données de surveillance post-marché par groupe de produits (PMS Plan, PSUR, analyse IMDRF...)
Coordonner la gestion des principaux problèmes qualité produit, y compris l'analyse des root causes, les NC/ CAPA et les analyses de tendance.
Suivre et élaborer les rapports d'indicateurs clés de performance de la qualité, l'analyse des tendances.
Déterminer le potentiel d'amélioration des processus liés à la qualité en utilisant une méthodologie et des outils spécifiques (ex FMEA).
Soutien en cas d'audits d'Organismes Notifiés / autorité.
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. Une expérience du Système TrackWise et Product Documentation Management - WindChill sont un plus. Votre anglais est courant. Rigueur, esprit d'analyse, autonomie, sens de l'organisation, réactivité et esprit d'initiative sont des qualités qui vous définissent.
Autres
Fresenius Medical Care à L'Arbresle offre un environnement de travail stimulant et des avantages sociaux compétitifs. Vous aurez l'occasion de contribuer à la qualité de vie des patients dialysés et de faire partie d'une équipe motivée et professionnelle.
