{"id":3168,"date":"2026-05-16T16:18:50","date_gmt":"2026-05-16T14:18:50","guid":{"rendered":"https:\/\/www.bayoo.net\/non-classe\/expert-en-gestion-des-risques-et-de-la-qualite-h-f\/"},"modified":"2026-05-16T16:18:50","modified_gmt":"2026-05-16T14:18:50","slug":"expert-en-gestion-des-risques-et-de-la-qualite-h-f","status":"publish","type":"post","link":"https:\/\/www.bayoo.net\/fr\/emplois-et-carrieres\/expert-en-gestion-des-risques-et-de-la-qualite-h-f\/","title":{"rendered":"Expert en gestion des risques et de la qualit\u00e9 (h\/f)"},"content":{"rendered":"

Vos t\u00e2ches<\/h2><\/div>
    \n
  • Planification et \u00e9laboration d’analyses et d’\u00e9valuations des risques pour les dispositifs m\u00e9dicaux<\/li>\n
  • Cr\u00e9ation d’AMDE logicielle<\/li>\n
  • Responsabilit\u00e9 de la gestion des risques selon la norme ISO 1497 :\n
      \n
    • Identifier les risques potentiels li\u00e9s aux dispositifs m\u00e9dicaux et \u00e0 leurs accessoires<\/li>\n
    • Estimation et \u00e9valuation des risques<\/li>\n<\/ul>\n<\/li>\n
    • Servir d’interface entre les clients et nos \u00e9quipes de d\u00e9veloppement<\/li>\n
    • responsabilit\u00e9 de la cr\u00e9ation, de la mise en \u0153uvre et de la mise \u00e0 jour des processus et de la documentation pour les dispositifs m\u00e9dicaux concern\u00e9s<\/li>\n<\/ul>\n<\/div>

      Votre profil<\/h2><\/div>
        \n
      • Dipl\u00f4me en technologie m\u00e9dicale, informatique, gestion de la sant\u00e9 ou qualification \u00e9quivalente<\/li>\n
      • Plusieurs ann\u00e9es d’exp\u00e9rience professionnelle dans la gestion des risques selon la norme ISO 14971<\/li>\n
      • Connaissance approfondie du r\u00e8glement sur les dispositifs m\u00e9dicaux (MDR), ainsi que des proc\u00e9dures d’autorisation dans d’autres pays (\u00c9tats-Unis, Canada, etc.)<\/li>\n
      • la capacit\u00e9 \u00e0 s’adapter rapidement \u00e0 de nouveaux sujets techniques et professionnels<\/li>\n
      • Une forte orientation client et de la rigueur<\/li>\n
      • Proactif, autonome et orient\u00e9 vers les solutions<\/li>\n
      • connaissance des exigences en mati\u00e8re de documentation conform\u00e9ment \u00e0 la norme ISO 13485<\/li>\n
      • Tr\u00e8s bonne ma\u00eetrise de l’allemand et de l’anglais \u00e0 l’oral et \u00e0 l’\u00e9crit<\/li>\n<\/ul>\n

        En plus de votre savoir-faire technique et professionnel, vous avez des comp\u00e9tences sociales. Tu es fiable, engag\u00e9 et flexible. Tu es capable d’\u00e9couter activement et d’analyser les besoins des clients de mani\u00e8re approfondie et tu as une grande autonomie ainsi qu’une grande capacit\u00e9 \u00e0 travailler en \u00e9quipe. Par-dessus tout, vous \u00eates un(e) penseur(se). <\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

        Vous \u00eates responsable des analyses de risques et des AMDEC logicielles pour les dispositifs m\u00e9dicaux conform\u00e9ment \u00e0 la norme ISO 14971, jouez le r\u00f4le d’interface entre les clients et les \u00e9quipes de d\u00e9veloppement et veillez \u00e0 ce que les processus et la documentation soient conformes aux normes, conform\u00e9ment au MDR et \u00e0 la norme ISO 13485.<\/p>\n","protected":false},"author":5,"featured_media":2466,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[134],"tags":[],"job-standort":[101,102,104],"job-bereich":[150],"job-arbeitszeit":[164,161],"job-gmbh":[85],"class_list":["post-3168","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-emplois-et-carrieres","job-standort-berlin","job-standort-darmstadt","job-standort-munich","job-bereich-requirements-engineering","job-arbeitszeit-teilzeit","job-arbeitszeit-vollzeit","job-gmbh-bayoomed"],"yoast_head":"\nExpert en gestion des risques et de la qualit\u00e9 (h\/f) - 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