Document Control Clerk

5 days ago


Québec, Canada Zimmer Biomet Full time

-Requisition Number
AMER24380
Employment Type
Full-time
Location
Montreal, Quebec

**Job Summary**:

- TECHNICIEN.NE - CONTRÔLE DES DOCUMENTS
- Zimmer Biomet est un leader mondial dans le secteur des dispositifs médicaux spécialisés en soins musculosquelettiques. À Montréal, Zimmer CAS représente la division de haute technologie de la compagnie.
- En joignant l’une de nos équipes, vous participerez au développement de solutions innovantes qui soutiennent les chirurgiens orthopédiques et cliniciens dans le soulagement de la douleur de leurs patients, et contribuerez ainsi à améliorer la qualité de vie de milliers de personnes à travers le monde.
- Pour mettre en action les valeurs qui nous motivent, nous pensons qu’il est nécessaire de prendre soin de notre communauté et de notre environnement. Parallèlement à vos défis professionnels, vous pourrez vous impliquer dans l’une de nos initiatives sociales, caritatives ou environnementales.- Sommaires
- Effectue des tâches administratives au sein du service de la qualité. A cet effet, maintient et sécurise les fichiers d'enregistrement principaux des appareils désignés. Reproduit et distribue des dessins de production, de processus et/ou de gabarit. De plus, maintien, reproduit et distribue les avis de modification, les spécifications techniques de Zimmer et d'autres documents liés au système qualité. Vérifie les ordres de production et les libère dans les zones de production. Veille à ce que les enregistrements de l'historique des appareils sont transférés dans une zone sécurisée et restreinte. Maintien et sécurise les enregistrements de qualité pour Zimmer CAS, avec un minimum de supervision et agit de manière indépendante conformément aux pratiques et procédures établies. Aussi, fournit un soutien et une assistance pour:
- Le pilotage du processus de contrôle des documents de l'entreprise et accompagnement des utilisateurs finaux pour l'organisation et l'utilisation du système de gestion électronique des documents (GED).
- La coordination des audits externes/internes et de toute formation requise
- _________________________________________________
- Maintain and secure designated device master record files. Reproduce and distribute production, process, and/or gage drawings. Also, maintain, reproduce and distribute Engineering Change Notices, Zimmer Engineering Specifications, and other quality system-related documents. Verify production order packets and release these to production areas. Manage and assure Device History Records are transferred to a secure and restricted area. Maintain and secure quality records for Zimmer Manufacturing B.V. Work with mínimal supervision and be capable of independent action following established practices and procedures.**Principal Duties and Responsibilities**:

- Principales tâches et responsabilités- Effectue des tâches administratives au sein du service de la qualité. Interagit et communique avec d'autres sites de Zimmer Biomet, selon les besoins.
- Gère et tient à jour les journaux et les listes de qualité (ex : déviations, procédures, TCP). Vérifie les documents et les plans selon les procédures internes.
- Effectue le traitement des procédures internes, y compris sa révision, son suivi et sa publication. Met en forme et relis les procédures et documents, incluent les modifications demandées.
- Gère les avis de modification conformément aux procédures internes correspondantes.
- Maintien et sécurise les procédures de première production, les enregistrements de validation et de qualification, les livres de transfert, et est responsable de la conservation des fichiers tel que défini dans la procédure correspondante, etc.
- S'assure que la révision du dessin est conforme à la révision du système informatisé électronique et fournit l'impression du dessin au besoin.
- Imprime les dessins (ex : production, outillage, etc.) du système informatique.
- Collecte les bons de travail fermés (enregistrements de l'historique des appareils), les saisi dans la base de données et les transfère à l’endroit approprié. Prépare des rapports requis.
- Lors que requis, fournit une assistance et un soutien au spécialiste du contrôle des documents concernant les procédures, la gestion de la formation et toute autre activité. Il ne s'agit pas d'une liste exhaustive de devoirs ou de fonctions et ne comprend pas nécessairement toutes les fonctions essentielles aux fins de l'Americans with Disabilities Act.
- __________________________________________________
- Continued contact either personal, telephone, and/or electronic mail with Warsaw and Zimmer Manufacturing personnel.
- Maintain logs for Deviations, NCMR’s, forms and others, etc. Check documents and drawings for proper stamps and reproduction quality.
- Maintain and secure First Production Routers, Validation and Qualification Records, Transfer Books, CAPA and responsible for the retention of fil



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