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    Manager Validation - Bern, Schweiz - Michael Page Switzerland

    Michael Page Switzerland
    Michael Page Switzerland Bern, Schweiz

    Gefunden in: Talent CH C2 - vor 1 Woche

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    Beschreibung

    Notreclient est une entreprise internationale spécialisée dans ledéveloppement de dispositifsmédicaux.

    Informations surl'entreprise

    • Entreprise internationale
    • Dispositifs médicaux

    Missions

    • Gérer les processus de V&V (Vérification andValidation) des équipements et de fabrication (emballage,transports...)
    • Mener des validations et rédigerles rapports de qualifications (IQ, OQ, PQ)
    • Gérer le processus de Conception etDéveloppement
    • Gérer le Processus de « RiskManagement » en collaboration avec tous les départements
    • Conduire de nouveaux projets avec la Direction pour lamise sur le marché de dispositifs médicaux classe III
    • Participer à la gestion des Dossiers Techniques encollaboration avec le responsable des AffairesRèglementaires
    • Participer aux auditexternes
    • Participer à des auditsinternes
    • Collaborer avec la Qualité dans lesuivi des CAPA
    • Participer à l'améliorationcontinue des processus de fabrication ainsi que de la qualité desproduits
    • Participer à l'animation deformations internes

    Profil ducandidat

    • Minimum 2-3ans de pratique dans un poste similaire
    • Expérience en validation obligatoire
    • Bonne maîtrise des aspects légaux, réglementaires etnormatifs dans le domaine des dispositifs médicaux (ISO 13485, ISO14971, directive 93/42/ECC et du règlement (UE) 2017/745 relatifaux dispositifs médicaux(RDM)
    • Diplôme d'ingénieurou équivalent, idéalement dans un domaine scientifique, mécaniqueou de la santé
    • Langue française et anglaiseobligatoires, espagnol et/ou allemand un atout

    Conditions etAvantages

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


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