Quality Assurance Manager Production

Job Description Summary

As a Quality Assurance Manager, you will ensure the quality and compliance of documents, products, and services for one or more modalities. You will participate in the maintenance of the Quality Management System (QMS), provide training, and guide internal teams in implementing QMS strategies and identifying necessary quality actions. This role is responsible for ensuring the compliance of projects and products developed and manufactured by the 'Advanced Visualization Solutions - Ultrasound Probes' modality. The position involves hands-on tasks in design, design transfer, manufacturing, and post-market surveillance, collaborating with development, production, supplier quality engineers, and regulatory affairs. External collaboration includes working with suppliers, customers, and regulatory authorities.

Within a human-sized organization located in the Sophia Antipolis technopole, you will join a Quality team dedicated to patient and customer needs. You will support the production teams for future ultrasound components and probes. You will continue to learn from international and multidisciplinary teams, with the goal of maintaining patient safety and image accuracy at the core of our medical devices.

Roles and Responsibilities

• Review documentation created by teams and ensure deliverables comply with QMS procedures.
• Guide and support employees in creating deliverables that adhere to procedures.
• Approve documents compliant with the QMS as the Quality Assurance (QA) representative.
• Collaborate with functional teams to resolve quality or compliance issues.
• Evaluate, escalate, and contain risks related to quality, safety, or non-compliance.
• Make quality decisions concerning finished products and services (release, quarantine non-conforming products, validate quality decisions).
• Contribute to the evaluation of Non-Conformities related to products, services, or processes; review and approve actions taken (corrections, investigations, and CAPAs).
• Assess the impact of major QMS updates within your area of expertise and implement corresponding changes to local processes, products, and documents.
• Develop training materials and train personnel affected by quality system changes.
• Participate in internal audits and maintain associated documentation.
• Guide teams on responses during external audits and regulatory inspections.
• Collaborate with functional managers and project leaders to define activities and strategies for implementing procedures and corrective action plans.
• Respond to auditors during external audits and regulatory inspections.

Required Qualifications

• A higher education degree in quality assurance, law, medicine, pharmacy, engineering, or another relevant scientific discipline.
• Proven professional experience in regulatory affairs or quality management systems related to medical devices.
• Training and experience as a Quality Assurance auditor or equivalent (desirable), or at least the ability to identify non-conformities against the applicable site framework.
• Advanced written and oral English proficiency. Ability to understand technical documentation in English.

Desired Skills

• Recognized knowledge of quality management system tools and continuous improvement methodologies. Experience in continuous improvement projects (Lean, Six Sigma).
• Recognized competence in effective communication at all organizational levels.
• Ability to understand and rigorously follow procedures.
• Demonstrated ability to make risk-based decisions (safety, compliance, quality).
• Ability to work independently and as part of a team.
• Experienced user of office suite tools.
• Excellent communication skills (ability to influence, negotiate, and unite).
• Demonstrated ability to identify problems, analyze them, and propose solutions and action plans aligned with regulatory and business constraints.
• Proven skills in managing large-scale projects.

Inclusion And Diversity

GE HealthCare is an equal opportunity employer where diversity counts. 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 characteristics protected by law.

Our total compensation is designed to unleash your ambition by giving you the motivation and flexibility you need to transform your ideas into world-changing realities. Our salaries and benefits reflect what you'd expect from an international organization, with career development opportunities in a culture that fosters collaboration and support.

About Us

GE HealthCare is a global leader in medical technology and digital solutions, enabling clinicians to make faster, more informed decisions through intelligent equipment, data analytics, applications, and services. With over 100 years of healthcare experience and approximately 47,000 employees worldwide, the company is at the heart of an ecosystem working towards precision medicine. Present in France since 1987 with 2,800 employees today, it is a firmly established player in France through its industrial footprint, its R&D and production center in Buc (Yvelines), and research partnerships with French companies and research centers.

www.gehealthcare.com

Key skills/competency

• Quality Assurance
• Medical Devices
• QMS
• Regulatory Affairs
• Auditing
• Risk Management
• Continuous Improvement
• Lean Six Sigma
• Compliance
• Project Management