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

Job Summary

As the Lead Quality Engineer, you will uphold and implement GE Healthcare’s Quality Policy (& QMS) on the Buc site in France, supporting design transfer and production teams through product continuity activities that impact customers and business. You will provide QMS support in accordance with documented procedures to ensure patient safety, reduce regulatory risk, and enable commercial delivery of GE Healthcare products. You are responsible for implementation and continuous improvement of established quality compliance practices.

Roles and Responsibilities

• Create a quality culture by driving compliance activities for GE Healthcare medical device products at the BUC manufacturing site.
• Ensure ongoing patient safety and regulatory compliance by providing total quality management system process support in accordance with documented procedures.
• Implement and continuously improve the total quality management system.
• Perform internal audits, support external audits, and promote product & process improvements through root cause analysis and CAPA.
• Act as the primary contact with auditors during external audits and regulatory inspections.
• Assess, elevate, 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.
• Oversee and manage all Quality Assurance activities on‑site under responsibility (CAPA, internal & external audits, inspections, QMS training, projects, etc.).
• Support manufacturing quality lead specialist activities, including management of design transfer and production continuity over the product lifecycle and support for the production line after implementation through non‑conforming product focal point & CAPA process ownership.

Qualifications

• Bachelor’s degree in a technical area or equivalent, or high school diploma with equal experience.
• Minimum 5 years of relevant experience in a regulated medical device environment, quality control/assurance or regulatory assurance.
• Knowledge of medical devices standards (ISO13485, 21CFR, IEC60601‑1, etc.).
• Fluent English; ability to travel to Grenoble several times per year.

Desired Characteristics

• Strong oral and written communication skills.
• Demonstrated ability to analyse and resolve problems.
• Experience with root cause analysis tools (fishbone, 5Why’s).
• Ability to develop, lead, and improve processes in a team environment.
• Expertise in communicating medical device regulations, QMS, CAPA, design & development, and production & process controls.
• Inclusive leadership: building trust, providing feedback and coaching to develop others.

Equal Opportunity Employment

GE Healthcare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other protected characteristics.