Senior Quality Assurance Engineer

6 days ago

Pune, Maharashtra, India beBeeQuality Full time ₹ 5,00,000 - ₹ 8,00,000

Design Quality Assurance

Key Responsibilities:

  • Be a core member of the project team and provide quality engineering support throughout the development cycle.
  • Lead product risk management, usability, reliability, and design validation efforts for new product development and design change projects.
  • Develop and implement design verification and validation plans in collaboration with the project design lead.
  • Create Critical to Quality (CTQ) documents, design inputs, and outputs.
  • Qualify fixtures and validate test methods.
  • Participate in Design of Experiments (DOE), FMEA sessions, Risk Management, and ensure compliance to CTQs and safety requirements.
  • Manage electronic document control and version control for all project-related documents.
  • Ensure adherence to the quality systems and design assurance SOPs.
  • Oversee usability, reliability, testing, verification, and validation testing with internal and external vendors.
  • Provide statistical testing and reliability plans.
  • Offer quality and regulatory compliance guidance as needed to product development or design change project teams to ensure country-specific compliance with laws and regulations of targeted markets.
  • Ensure the creation and proper execution of Project/Sustaining Quality Deliverables (e.g., Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
  • Co-Lead CAPA efforts, applying systematic problem-solving methodologies to identify, prioritize, communicate, and drive the resolution of quality issues (e.g., 5 Whys analysis, Is-Is Not analysis, and Six Sigma problem-solving methodologies).
  • Develop and implement effective quality assurance processes, controls, statistical analyses, and metrics to ensure products meet or exceed quality expectations.

Qualification and Experience:

  • Bachelor's degree in engineering (mechanical engineering preferred).
  • 5-9 years of experience in medical device quality engineering.
  • Professional training and certification 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 for Six Sigma, Risk Management, FMEA, FTA (Fault Tree Analysis).
  • Preference for candidates with CQE certification or similar training/experience.
  • Proficient in project management tools like MS Project.
  • Experience in GD&T.
  • Well-versed in statistical analytical techniques and software tools like MATLAB, MINITAB.

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