Quality Assurance Engineer-2

Found in: Talent IE C2 - 3 weeks ago


Dublin, Ireland Enovis Full time

Description de l'emploi:

ENOVIS est un groupe international leader dans la conception, la fabrication et la distribution de dispositifs médicaux. ENOVIS propose des solutions thérapeutiques et technologiques promouvant la santé sur le plan locomoteur et vasculaire, le traitement de la douleur, la préparation physique, la recherche de la performance et la récupération après l’effort. L’objectif affiché par DJO Global est "d'aider tous les patients à regagner le confort et le bonheur d’une mobilité naturelle".

Distribués dans plus de 80 pays, les produits du groupe DJO Global sont utilisés par de nombreux professionnels de santé : chirurgiens orthopédistes, neurochirurgiens, services d’urgences, centres de lutte contre la douleur, masseurs- kinésithérapeutes, chiropracteurs, médecins du sport, sages-femmes, etc.

Beaucoup de ces produits et accessoires sont également utilisés par des entraîneurs, préparateurs physiques, sportifs occasionnels ou de haut niveau, ainsi que par des particuliers dans le cadre de prévention de blessures ou dans le cadre de traitements à domicile.

DJO France, filiale française du groupe ENOVIS, compte plus de 305 employés en France et développe des produits pour toute l’Europe et les distribue auprès des pharmacies, hôpitaux et magasins spécialisés.

Dans le cadre d'un remplacement, DJO France recherche son Ingénieur Qualité Fournisseurs

Missions:

Évaluer et auditer les installations des fournisseurs, les produits et le système qualité pour s'assurer qu'ils soient conformes aux exigences réglementaires et vérifier les capacités et la qualité des fournisseurs. Examiner les non conformités liées aux fournisseurs et décider des actions à mener pour leur traitement

Participer activement à l’amélioration de la qualité en pilotant et vérifiant les plans d’amélioration issus des CAPA et leur efficacité et en réduisant les coûts de non qualité

Mesurer et développer les indicateurs actuels de performance des fournisseurs : DPPM, coût de non qualité, nombre de non conformités…

Soutenir le processus d'approbation des nouveaux fournisseurs, maintenir la liste des fournisseurs agréés en qualité de responsable de la qualité afin de garantir le respect des normes locales et mondiales et Revoir et approuver les procédures liées à la gestion des fournisseurs pour assurer leur conformité aux exigences réglementaires.

Soutenir le développement de nouveaux produits notamment sur les activités de transfert de conception pour assurer la qualification des pièces fabriquées par les fournisseurs

Aider et soutenir les audits des organismes notifiés, les inspections de la FDA et d'autres audits tiers.

Tout mettre en œuvre à son niveau pour atteindre les objectifs et cibles environnementales définies et faire remonter auprès de sa hiérarchie tout dysfonctionnement environnemental ou sécuritaire.

Profil :

Ecole Supérieure d’Ingénieur avec minimum 3 années d'expérience en Qualité idéalement dans le domaine biomédical ou dispositifs médicaux

Bonne connaissance des règlementations du DM : ISO13485, MDR, FDA/GMP, CMDR

Expérience d’auditeur externe et idéalement certification d’auditeur Qualité (ex : IRCA)

Anglais courant impératif oral et écrit

EOE AA M/F/VET/Déclaration d'invalidité

Tous les candidats qualifiés seront pris en considération pour un emploi et ne feront l'objet d'aucune discrimination fondée sur la race, la religion, la couleur, l'origine nationale, le sexe, le statut de vétéran protégé, le handicap ou toute autre base protégée par les lois fédérales, nationales ou locales.


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