Responsable Assurance Qualite (CDD) - Region Quality Assurance Leader (fixed-term) - FBL&IB

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Job Description Summary As the QA Leader for France, Belgium, Luxemburg and Iberia (Spain and Portugal), you will lead and coordinate all Quality Assurance (QA) activities for a strategic cluster of European Countries. This zone brings together a diverse set of markets with mature healthcare systems, strong regulatory environments, and high standards for quality and compliance. You will be responsible for implementing and maintaining the Quality Management System (QMS), supporting audits and inspections, and acting as the primary QA interface for Sales and Service teams in the zone. You will collaborate closely with the regional Regulatory Affairs (RA) team, QA peers in the larger European Zones & INTERNATIONAL region, as well as global quality functions to ensure alignment with standards and global expectations. This is a fixed-term maternity cover position. Job Description Roles and Responsibilities Act as the focal point for QA in FBL & IB, supporting Sales, Service, and operational teams. Participate in the maintenance and update of the QMS, including local procedures. Ensure understanding and adherence to quality procedures across the Region. Support internal and external audits, including regulatory inspections. Facilitate regional response to urgent reportability clarification requests raised by the Complaint Handling Unit. Monitor and report on QMS training status; co-accountable for training completion in the zone. Provide guidance to business managers on quality topics and regulatory expectations. Drive the CAPA process by identifying quality concerns, conducting spot audits, and ensuring timely closure of actions. Lead or support quality improvement projects and quality plans (e.g. setup of a new operation, office moves, new process introduction). Manage deviation/concession processes and ensure compliance with tool calibration and OOT requirements. Support channel partner quality oversight, including Annex Q adherence and audit readiness. Collaborate with the Supplier Quality team to ensure use of qualified suppliers. Support closure of customer complaints, field actions, and non-conformances. Participate in remote internal audits as lead auditor or SME. Collaborate with the regional RA team to ensure alignment on regulatory requirements, audit readiness, and product compliance. Represent FBL&IB in the International region and global QA forums and initiatives. Required Qualifications Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field. Important experience in Quality Assurance within the medical device, healthcare, or regulated industry. Strong knowledge of ISO 13485, and other applicable international regulations. Experience in internal and external audits, including regulatory inspections. Proven ability to manage QMS documentation, training, and compliance activities. Excellent English and French communication skills (written and spoken). Organizational, analytical, and leadership skills. Ability to work and to travel independently and collaboratively across diverse cultures and geographies. Desired Characteristics Advanced degree (e.g., MSc, MBA) or professional certifications (e.g., ASQ CQA, Lead Auditor). Experience in a regional QA leadership role. Familiarity with Sales and Service operations in FBL&IB. Experience with CRM systems, field service quality, and digital tools. Cultural agility and ability to influence across functions and levels. Willingness to travel across the region as needed. Résumé du poste En tant que Responsable QA pour la France, la Belgique, le Luxembourg et l'Ibérie (Espagne et Portugal), vous dirigerez et coordonnerez l'ensemble des activités d'Assurance Qualité (QA) pour un cluster stratégique de pays européens. Cette zone regroupe divers marchés caractérisés par des systèmes de santé matures, des environnements réglementaires solides, ainsi que des exigences élevées en matière de qualité et de conformité. Vous serez responsable de la mise en œuvre et du maintien du Système de Management de la Qualité (QMS), du support aux audits et inspections, et vous agirez en tant qu'interface QA principale pour les équipes commerciales et de service dans la zone. Vous collaborerez étroitement avec l'équipe régionale des Affaires Réglementaires (RA), les homologues QA dans les autres zones européennes et la région INTERNATIONAL, ainsi qu'avec les fonctions qualité globales afin de garantir l'alignement avec les standards et les attentes globales. Il s'agit d'un poste en CDD dans le cadre d'un remplacement de congé maternité. Rôles et responsabilités Agir en tant que point de contact principal QA pour FBL & IB, en soutenant les équipes commerciales, de service et opérationnelles. Participer au maintien et à la mise à jour du QMS, y compris les procédures locales. Garantir la compréhension et le respect des procédures qualité dans la région. Soutenir les audits internes et externes, y compris les inspecti

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