Design Quality Assurance

2 days ago

Pune, Maharashtra, India Capgemini Engineering Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Position:- Design Quality AssuranceDomain :- Medical (Mandatory)Location :- PuneExperience – 4-6 yrs

Notice Period :- May Joiners (ONLY)DQA Keywords: Medical Device, QMS, Quality Management Systems ,ISO 13485, Risk management, Hazard Analysis.CAPA, PSURKey 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. Qualification and Experience:-Bachelors (or higher) degree in engineering with preference of engineering background.7-9 years of experience in medical device quality engineering.

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&Thaving experience on statistical tool like, MINITAB.
At Capgemini, we aim to attract the best talent and are committed to creating a diverse and inclusive work environment, so there is no discrimination based on race, sex, sexual orientation, gender identity or expression, or any other characteristic of a person.

All applications welcome and will be considered based on merit against the job and/or experience for the position.

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