Responsable Assurance Qualité - Production (H/F)
GE HealthCare · Valbonne, Provence-Alpes-Côte d'Azur, France
- On site
- Full-time
- €85,000 / year
- Valbonne, Provence-Alpes-Côte d'Azur, France
Job highlights
- Ensure quality and compliance for medical devices.
- Maintain and implement Quality Management System.
- Collaborate with cross-functional international teams.
- Drive quality decisions for products and services.
- Contribute to patient safety and device accuracy.
About the role
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
Skills & topics
- Quality Assurance Manager
- Quality Assurance
- Production
- Medical Devices
- QMS
- Regulatory Affairs
- Auditing
- Risk Management
- Compliance
- GE HealthCare
- Sophia Antipolis
- Lean
- Six Sigma
- French
How to get hired
- Tailor your resume: Highlight your experience in medical device quality assurance, QMS, and regulatory compliance.
- Showcase relevant skills: Emphasize your expertise in auditing, risk management, and continuous improvement methodologies like Lean Six Sigma.
- Demonstrate English proficiency: Clearly state your advanced written and oral English skills, mentioning your ability to handle technical documentation.
- Prepare for interviews: Be ready to discuss your decision-making process, problem-solving approach, and experience with audits and regulatory inspections.
- Research GE HealthCare: Understand their mission, values, and commitment to precision medicine and patient safety.
Technical preparation
Behavioral questions
Frequently asked questions
- What specific experience is required for the Quality Assurance Manager Production role at GE HealthCare?
- The Quality Assurance Manager Production role at GE HealthCare requires proven professional experience in regulatory affairs or quality management systems specifically related to medical devices. A higher education degree in a relevant scientific field is also mandatory. Experience as a QA auditor is desirable.
- What are the key responsibilities of the Quality Assurance Manager Production at GE HealthCare's Sophia Antipolis site?
- Key responsibilities include ensuring product and document compliance with the QMS, guiding teams, approving documents, resolving quality issues, managing risks, making quality decisions on finished products, evaluating non-conformities, and participating in audits. You'll focus on ultrasound probe development and manufacturing.
- Is English proficiency essential for this Quality Assurance Manager role at GE HealthCare?
- Yes, advanced written and oral English proficiency is essential. You must be able to understand technical documentation in English as collaboration with international teams and handling of documentation will be part of your role.
- What kind of projects will the Quality Assurance Manager Production be involved in at GE HealthCare?
- The Quality Assurance Manager Production will be involved in ensuring compliance for projects and products developed and manufactured by the 'Advanced Visualization Solutions - Ultrasound Probes' modality. This includes design, design transfer, manufacturing, and post-market surveillance.
- Does GE HealthCare offer relocation assistance for this Quality Assurance Manager Production position in Sophia Antipolis?
- Based on the provided information, relocation assistance is not offered for this Quality Assurance Manager Production position.
- What are the 'Desired Skills' for the Quality Assurance Manager Production role at GE HealthCare?
- Desired skills include knowledge of QMS tools, continuous improvement methodologies (Lean, Six Sigma), effective communication, ability to follow procedures rigorously, risk-based decision-making, teamwork, proficiency in office tools, problem analysis, and project management.
- What is the typical career growth path for a Quality Assurance Manager at GE HealthCare?
- GE HealthCare emphasizes career development opportunities within a collaborative culture. For a Quality Assurance Manager, growth could involve moving into broader quality leadership roles, specializing in regulatory affairs, or leading larger, more complex quality initiatives within the organization.