Manager Validation

vor 1 Monat


Bern, Schweiz Michael Page Vollzeit
  • 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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