Product Quality and Risk Management Specialist
il y a 4 semaines
Missions
Fresenius Medical Care, acteur mondial de la santé, offre des produits et services pour les maladies rénales et les hôpitaux. Notre site de L'Arbresle est un exemple de notre engagement envers la qualité et la sécurité des patients.
Nous recherchons un(e) Product Quality and Risk Management Support pour rejoindre notre département Design Control & Product Center Concentrates & Disinfectants.
Vos principales activités seront :
- Compléter et gérer les dossiers d'analyse de risques produit pour les groupes de produits concernés
- Être en lien 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
Nous recherchons un(e) candidat(e) ayant un bac+5 (ingénieur, master...) avec une expérience de 5 ans dans le domaine des affaires réglementaires ou de la qualité (secteur pharmaceutique/médical).
Nous recherchons également 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.).
Une expérience du Système TrackWise et Product Documentation Management - WindChill sont un plus.
Autres
Nous offrons un environnement de travail dynamique et stimulant, avec des opportunités de développement professionnel et des avantages sociaux compétitifs.
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