Design Quality Assurance

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the worlds mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe same.

About The Role ::

Bachelors (or higher) degree in engineering with preference mechanical engineering.

5-9 years of experience in medical device quality engineering.

Primary Skills:

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

Secondary Skills:

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.