Quality Control Senior Operator

Il y a 5 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.

L’Opérateur/Technicien Contrôle Qualité effectue le contrôle à réception / en cours et/ou final et assure une conformité des matières premières / composants / produits finis achetés ou fabriqués conformément aux spécifications établies.

CONNAISSANCES PROFESSIONNELLES SPECIFIQUES
- Connaitre les produits de la gamme Micro-France, leurs étapes de fabrication et les techniques spécifiques à leurs contrôles
- Pratique d’ERP, Word, Excel et autres éléments de la suite Office
- Connaitre la réglementation des dispositifs médicaux et/ou savoir où chercher l'information (ISO 13485, MDSAP, ISO 2859)
- Comprendre la norme ISO 2859-1 (règles d'échantillonnage pour les contrôles)
- Avoir une aisance relationnelle transverse, savoir prendre du recul et remonter les difficultés
- Utiliser des outils de mesure (CME) conformément aux instructions de contrôle
- Savoir lire un plan dimensionnel
- Savoir lire des spécifications

DESCRIPTION DES ACTIVITES SIGNIFICATIVES
- L’activité nécessite la réalisation d’activités similaires, l’identification des anomalies, la mise en œuvre de modes opératoires répertoriés:

- Conformément aux procédures et instructions, réalise la libération des matières premières et composants et produits finis sous traités
- Réalise la libération des dossiers de lots de produits finis et SAV
- Contrôle sur échantillonnage et selon les instructions les matières premières et composants et produits finis (lire un plan et des spécifications et utiliser des outils de mesure adaptés au contrôle)
- Réalise un audit flash selon le plan d’audit défini avec le Superviseur Qualité Système
- Présente son activité aux auditeurs et inspecteurs lors des audits et inspections
- Mets en quarantaine des produits finis impliqués par une non-conformité
- Mets en quarantaine des matières premières et composants impliqués par une non-conformité
- Mets en prison des produits en attente d'investigation
- Relaye la culture qualité au sein du site
- Est support technique pour la documentation associée au poste de travail
- Mets à jour un ou plusieurs indicateurs permettant le suivi de l'activité
- Maintien les instructions de travail à jour : mettre à jour les instructions de travail et/ou alerter la hiérarchie des dérives identifiées
- Conditionnement des produits distribués
- Mise en quarantaine ou prison des produits présentant une anomalie
- Stopper la réception après accord avec la hiérarchie en cas de problématique qualité détectée lors d’un contrôle
- Assure le contrôle selon le plan d’échantillonnage
- Prendre toute décision liée à son périmètre d’organisation pour respecter les engagements concernant la Qualité des produits livrés, la sécurité des patients, les délais de production


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