Quality Operational Technician

Il y a 3 mois


Bordeaux, France Integra LifeSciences Temps plein

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Vous serez chargé de la mise en œuvre et de la gestion des activités liées à l’assurance qualité au sein de l’entreprise. Votre rôle principal consistera à veiller à ce que les processus opérationnels respectent les normes de qualité et les réglementations en vigueur. Vous travaillerez en étroite collaboration avec les équipes de production, d’achat, d’ingénierie et les responsables qualité pour garantir la conformité des produits aux exigences internes et externes.

Responsabilités:

- Maitrise de la qualité : Effectuer des contrôles réguliers sur les lignes de production pour s’assurer que les produits sont conformes aux spécifications et normes qualités établies.
- Gestion des non-conformités : Traitement, investigation, plan d’action, clôture. Suivi d’indicateurs, pareto des causes à intervalles périodiques.
- Analyses et rapports : Collecter et analyser les données de contrôle qualité, préparer des rapports et communiquer les résultats aux parties prenantes concernées en français et en anglais.
- Suivi des indicateurs de performance : Surveiller les indicateurs de qualité opérationnelle et proposer des plans d’amélioration continue.
- Formation : Assurer la formation du personnel aux bonnes pratiques de qualité et aux procédures opérationnelles.
- Documentation : Participer à la rédaction et à la mise à jour des procédures qualité, des instructions de travail et des documents liés à l’assurance qualité.
- Support technique : Fournir un support technique aux équipes opérationnelles pour résoudre les problèmes de qualité et mettre en place des actions correctives.
- Veille réglementaire : Rester informé des évolutions réglementaires liées à la qualité et s’assurer de la conformité de l’entreprise.

Qualifications:

- Formation : Diplôme Bac+2 technique ou équivalent dans le domaine de la qualité, de la production ou d’une discipline connexe.
- Connaissances : bonne compréhension des méthodes et des outils d’assurance qualité (comme les 5S, les audits qualité, les outils statistiques, etc.).
- Expérience : Une expérience préalable dans un poste similaire en assurance qualité ou dans le domaine médical (ISO13485).

Compétences techniques:

- Maîtrise des outils informatiques et de bureautique (Excel, Word, etc.).
- Lecture de dessins techniques : compréhension des spécifications techniques détaillées sur les plans, y compris les tolérances, les dimensions critiques, les matériaux utilisés, les cotes géométriques, etc.
- Connaissance des normes qualité : familiarité avec les normes de qualité courantes telles que ISO 9001 et ISO13485, ainsi que la capacité à appliquer ces normes dans les processus de travail.
- Logiciels de gestion de la qualité : utilisation de logiciel dédiés à la gestion de la qualité pour documenter les procédures, gérer les non-conformités et générer des rapports de non-conformités.
- Analyse des causes racines : compétence pour mener des analyses approfondies afin d’identifier les causes sous-jacentes des problèmes de qualité et proposer des solutions appropriées.
- Audit qualité : capacité à mener des audits internes pour évaluer l’efficacité des processus et des systèmes qualité de l’entreprise.



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