Quality Lead Specialist / Spécialiste qualité principal (H/F)

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Job Description Summary Quality Lead Engineer Job Description summary As the Lead Quality Engineer, you are responsible for upholding and implementing the GE Healthcare Quality Policy & Quality Management System for GE Healthcare on Buc site in France. You will support design transfer and production teams through product continuity activities with direct customer and business impact. You will provide QMS (Quality Management process) support in accordance with documented procedures and practices in order to ensure patient safety, reduce regulatory risk, and enable commercial delivery of GE Healthcare products. You are responsible for the implementation and continuous improvement of established quality compliance practices. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Ingénieur qualité principal Résumé de la description de poste En tant qu'Ingénieur qualité principal vous êtes responsable de maintenir et de mettre en œuvre la politique qualité et le système de management de la qualité (QMS) de GE Healthcare sur le site de Buc en France. Vous soutenez les équipes de transfert de conception et de production à travers des activités de continuité des produits ayant un impact direct sur les clients et les activités. Vous fournissez un support QMS (processus de management de la qualité) conformément aux procédures et pratiques documentées afin d'assurer la sécurité des patients, de réduire les risques réglementaires et de permettre la livraison commerciale des produits GE Healthcare. Vous êtes responsable de la mise en œuvre et de l'amélioration continue des pratiques de conformité qualité établies. GE Healthcare est un leader mondial des technologies médicales et des solutions digitales. Notre mission est d'améliorer les vies dans les moments qui comptent. Libérez votre ambition, transformez vos idées en réalités qui changent le monde et rejoignez une organisation où chaque voix compte et où chaque contribution construit un monde plus sain. Job Description Roles and Responsibilities Create a Quality culture by driving compliance activities for GEHC medical device products at the BUC manufacturing site. Ensure ongoing patient safety, regulatory compliance of GE Healthcare products by providing total quality management system process support in accordance with documented procedures and practices. Responsible for implementing and continuously improving the total quality management system. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Performs internal audits, supports external audits, and promotes product and process improvements through root cause analysis and CAPA process. Main activities Quality Site Leader Participate in defining the site's strategic directions together with the relevant cross-functional leadership team. Act as the primary contact with auditors during external audits and regulatory inspections. Assess, escalate, and contain quality, safety, or compliance risks. Ensure the effectiveness and compliance of the site Quality Management System (QMS). Lead the maintenance, deployment, and continuous improvement of the site QMS. Participate in defining the site's strategic directions together with the relevant cross-functional leadership team. Act as the primary contact with auditors during external audits and regulatory inspections. Ensure the execution and compliance of all Quality Assurance activities within the entity under their responsibility, including CAPA, internal and external audits, inspections, QMS training, projects, QMS maintenance, and quarterly management reviews. Oversee and manage all Quality Assurance activities on-site under their responsibility (CAPA, internal and external audits, inspections, QMS training, projects, etc.). Note: These activities will be performed remotely in coordination with the GEHC Grenoble site. Manufacturing quality lead specialist QA Management of design transfer and production continuity activity over the product lifecycle for the Grenoble site production transfer to Buc site Support for the production line after implementation through non conforming product focal point, CAPA process owner. Above responsabilities as site leader including manufacturing activities. Required Qualifications Bachelor's degree from an accredited university/college or a high school diploma in a technical area or equivalent knowledge Minimum of 5 years of related work experience (e.g. experience working in a regulated medical device environment, quality control/assurance or regulatory assurance) Knowledge of medical devices standards (ISO 13485, 21 CFR, IEC 60601-1..) Technical competencies Fluent English Note : Travel to Grenoble seve

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