Spécialiste Assurance Qualité- Vigilance (Rungis) H/F job opportunity at Abbott.



DatePosted 5 Days Ago bot
Abbott Spécialiste Assurance Qualité- Vigilance (Rungis) H/F
Experience: General
Pattern: full-time
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loacation France > Rungis : Miami Building, France
loacation France > Rungi..........France

      JOB DESCRIPTION: Mission principale: Support du Responsable Assurance Qualité ADC France Accompagner le Responsable Qualité dans la mise en place de la Politique Qualité de l'entreprise en l'associant à des indicateurs et processus de contrôle Soutenir le Responsable Qualité dans la mise en oeuvre des procédures Qualité pour répondre aux exigences Abbott et ISO 13485: 2016 Supporter le Responsable Qualité dans le suivi de l'activité Vigilance Missions: S'assurer que toutes les activités sont réalisées en conformité avec les exigences du Système Qualité en place S'assurer que la Division respecte les normes ISO 13485: 2016 ainsi que les procédures Abbott / ADC Participer à la mise en place du programme MIMS (Multi Integrated Management System) pour la division Participer aux audits et inspections internes/ externes Participer à la mise en place d'indicateurs pertinents par les différents départements Participer aux groupes de travail français et internationaux MIMS et ADC Participer aux mise à jour des procédures en relation avec le support juridique, OEC et le Spécialiste Règlementaire Participer à l'évaluation, au suivi des fournisseurs / distributeurs Participer à la gestion des CAPA Soutenir les équipes dans l'élaboration des instructions de travail locales Soutenir le Responsable Qualité dans le processus Vigilance Participer à la formation des nouveaux entrants sur les processus Qualité Profil recherché: Bac + 2 ou Bac + 3 dans les filières scientifiques ou techniques Connaissance de l'Assurance Qualité pour les DM et DMDIV Connaissance de la Norme ISO 13485: 2016 Connaissance des règlements UE2017_745 DM / UE2017_746 DMDIV ainsi que le règlement GDPR Connaissances: CAPA, Field Action, Contrôle Documentaire, Audit-Evaluation des fournisseurs , distributeurs , procédures-achats Bonne aisance relationnelle, réactivité, adaptabilité, rigueur Anglais: opérationnel       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: ADC Diabetes Care          LOCATION: France > Rungis : Miami Building       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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