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.

Inclusion et diversité :

GE HealthCare est un employeur offrant l'égalité des chances où l'inclusion compte. Les décisions relatives à l'emploi sont prises sans tenir compte de l’origine nationale ou ethnique, de la religion, du sexe, de l'orientation sexuelle, de l'identité ou de l'expression de genre, de l'âge, du handicap, du statut d'ancien combattant protégé ou d'autres caractéristiques protégées par la loi.

Nos rémunérations totales sont conçues pour libérer votre ambition en vous donnant la motivation et la flexibilité dont vous avez besoin pour transformer vos idées en réalités qui changent le monde. Nos salaires et nos avantages sociaux correspondent à tout ce que vous attendez d’une organisation ayant une dimension internationale, avec des possibilités de développement de  carrière, dans une culture qui favorise la collaboration et le soutien.

A propos de nous :

GE HealthCare est l'un des leaders mondiaux dans le domaine des technologies médicales et des solutions numériques. Il permet aux cliniciens de prendre des décisions plus rapides et plus pertinentes à travers des équipements intelligents, des analyses de données, des applications et des services. Avec plus de 100 ans d'expérience dans le secteur de la santé et environ 47 000 employés dans le monde, la société est au centre d'un écosystème qui travaille pour une médecine de précision. Présent en France depuis 1987 avec aujourd’hui 2 800 collaborateurs, c’est un acteur solidement ancré dans l’hexagone à travers son empreinte industrielle, son centre de R&D et de production à Buc dans les Yvelines et des partenariats de recherche avec des entreprises et des centres de recherche français. www.gehealthcare.com

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