Design Quality Assurance
Job Summary
Job Description
- Bachelor's degree in engineering (preferred: mechanical).
- 5-9 years of medical device quality engineering experience.
- Training and certification in Quality Management Systems.
- Understanding of medical device regulatory requirements.
- Experience with project planning, resourcing, and budgets.
- CQE certification or similar training and experience.
- Proficiency in project management tools like MS Project.
- Experience in GD&T.
- Knowledge of statistical analytical techniques and software like MATLAB, MINITAB.
3 skills required
Job Details
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
- Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
- Lead the development and implementation of design verification and validation plans with project design lead.
- Lead the development of Critical to Quality (CTQs), design input and output documents.
- Lead the fixture qualification and test method validation.
- Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance to CTQ’s and safety requirements.
- Manage electronic document control and version control on all project related documents.
- Ensure adherence to the quality systems and design assurance SOPs .
- Lead usability, reliability, testing, verification and validation testing – internal and local vendors.
- Provide statistical testing and reliability plans.
Job Description - Grade Specific
Qualification and Experience:
- Bachelors (or higher) degree in engineering with preference mechanical engineering.
- 5-9 years of experience in medical device quality engineering.
- Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
- Sound understanding of medical device regulatory requirements for Class II and III medical devices.
- Project planning – resourcing, timelines, quality and budgets.
- Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
- Preference for candidates with CQE certification or similar training and experience
- Proficient in project management tools like MS project.
- Experience in GD&T
- Well versed with statistical analytical techniques and s/w tools like MATLAB, 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.
Similar Jobs
Looks like we're out of matches
Similar Skill Jobs
Looks like we're out of matches
Jobs in Pune, Maharashtra, India
Looks like we're out of matches
Similar Category Jobs
Looks like we're out of matches
