At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Job Description

Key Responsibilities:

• Be a part of core project team and support the quality engineering across the entire development cycle
• Participate in product risk management, usability, reliability and design validation efforts for new product development and design change projects.
• Contribute to the development and implementation of design verification and validation plans with project design lead.
• Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance.
• Manage electronic document control and version control on all project related documents.
• Having experience on adherence to the quality systems and design assurance SOPs of clients.
• Exposure with usability, reliability, testing, verification and validation testing – internal and local vendors.
• statistical skills and technical writing skills
• Provide quality and compliance guidance as needed to product development or design change project teams to assure country specific compliance .
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan,).
• Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and preferably Six Sigma problem solving methodologies).
• Devise and support the implementation of effective quality assurance, process controls, , and metrics that assure products meet or exceed quality.
  
  

Primary Skills

• Bachelors (or higher) degree in engineering with preference of engineering background.
• Professional training certification in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation is preferred.
• Sound understanding of medical device regulatory requirements for Class II and III medical devices.
• Preference for candidates with CQE certification or similar training and experience
• Proficient in project management tools like MS project.
• Experience in GD&T
• having experience on statistical tool like, MINITAB.
  
  

Capgemini is 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 fuelled 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.