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    Manager Validation - Bern, Schweiz - Michael Page

    Michael Page
    Michael Page background
    Beschreibung
    • Gérer les processus de V&V (Vérification and Validation) des équipements et de fabrication (emballage, transports...)
    • Mener des validations et rédiger les rapports de qualifications (IQ, OQ, PQ)
    • Gérer le processus de Conception et Développement
    • Gérer le Processus de « Risk Management » en collaboration avec tous les départements
    • Conduire de nouveaux projets avec la Direction pour la mise sur le marché de dispositifs médicaux classe III
    • Participer à la gestion des Dossiers Techniques en collaboration avec le responsable des Affaires Règlementaires
    • Participer aux audit externes
    • Participer à des audits internes
    • Collaborer avec la Qualité dans le suivi des CAPA
    • Participer à l'amélioration continue des processus de fabrication ainsi que de la qualité des produits
    • Participer à l'animation de formations internes
    • Minimum 2-3 ans de pratique dans un poste similaire
    • Expérience en validation obligatoire
    • Bonne maîtrise des aspects légaux, réglementaires et normatifs dans le domaine des dispositifs médicaux (ISO 13485, ISO 14971, directive 93/42/ECC et du règlement (UE) 2017/745 relatif aux dispositifs médicaux (RDM)
    • Diplôme d'ingénieur ou équivalent, idéalement dans un domaine scientifique, mécanique ou de la santé
    • Langue française et anglaise obligatoires, espagnol et/ou allemand un atout

    Une activité variée, passionnante et pleine de défis dans une entreprise à taille humaine.


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