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CQR Engineer

  • Job
    Full-time
    Senior Level
  • Consulting
    Engineering
  • Lyon

AI generated summary

  • You need a Bac+5 engineering degree, 5 years in medical device quality assurance, ISO 13485 expertise, project management skills, and fluent English. Experience with active/non-active implants is necessary.
  • You will implement and maintain quality management systems, conduct internal and external audits, manage risk processes, and analyze quality data to propose corrective actions for medical devices.

Requirements

  • De formation ingénieur ou équivalent (Bac+5), vous justifiez de minimum 5 ans d'expérience en assurance qualité dans le secteur des dispositifs médicaux :
  • Expertise avérée dans la norme ISO 13485 et les réglementations applicables aux dispositifs médicaux
  • Expérience significative dans le domaine des implants actifs, non-actifs, ou prothèses médicales
  • Compétences en gestion de projet et maîtrise des outils de gestion de la qualité
  • Anglais courant (écrit et oral) indispensable

Responsibilities

  • Mettre en place et maintenir le système de management de la qualité et de sa documentation (process, procédures, instructions), en conformité à la norme ISO 13485 et aux exigences spécifiques du Client
  • Participer à la gestion de l'assurance qualité dans les projets de conception, d’évolution (change) et de fabrication de dispositifs médicaux
  • Réaliser des audits internes et externes pour garantir la conformité aux normes et réglementations
  • Gérer les processus de gestion des risques (produits et process), validation et de vérification des dispositifs médicaux, en particulier des prothèses
  • Analyser les données qualité et proposer des actions correctives et préventives, esp. NC-CAPA

FAQs

What is the main focus of the CQR Engineer position at Capgemini Engineering?

The main focus is on quality assurance for medical devices, with an emphasis on adhering to ISO 13485 standards and managing the quality system documentation.

What qualifications are required for this role?

The candidate should have at least a Bac+5 in engineering or an equivalent field, along with a minimum of 5 years of experience in quality assurance within the medical devices sector.

Is expertise in ISO 13485 important for this position?

Yes, expertise in ISO 13485 and knowledge of applicable regulations for medical devices are essential.

Are there specific experience requirements related to the type of medical devices?

Yes, significant experience in active, non-active implants, or medical prostheses is required.

What project management skills are expected for this role?

Strong project management skills and mastery of quality management tools are expected.

Is fluency in English necessary for this position?

Yes, fluency in English, both written and oral, is mandatory.

What benefits does Capgemini Engineering offer its employees?

Capgemini Engineering offers flexible teleworking arrangements, continuous learning opportunities, and various group advantages like action plan participation, preferred pricing activities, and reimbursement for vacations and sports or cultural subscriptions.

What type of work environment can employees expect?

Employees can expect a supportive work environment with a focus on work-life balance, inclusivity, and a commitment to reducing environmental impact.

How does Capgemini Engineering support employee development?

Capgemini Engineering supports employee development through continuous learning programs, access to certifications and training, and personalized mentoring from career managers.

Is there an emphasis on corporate social responsibility at Capgemini Engineering?

Yes, Capgemini Engineering is committed to corporate social responsibility, promoting diversity, talent development, and initiatives to reduce environmental impact.

Capgemini Engineering, the leader in engineering and R&D services, helps clients unleash their R&D potential.

Technology
Industry
10,001+
Employees

Mission & Purpose

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 60,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet. Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.