Design Quality Assurance - Medical Devices

About the Role

Join our core project team and play a key role in quality engineering across the entire product development cycle for Class II & III medical devices . This position ensures compliance with global regulatory standards , drives risk management , and supports design assurance for innovative healthcare solutions.

Key Responsibilities

• Lead product risk management , usability , reliability , and design validation for new product development and design changes
• Develop and implement design verification & validation plans with project design leads
• Define Critical to Quality (CTQs) , design input/output documents, and ensure adherence to quality systems & SOPs
• Manage fixture qualification , test method validation , and electronic document control
• Conduct FMEA sessions , DOE , risk management , and ensure compliance with CTQs and safety requirements
• Provide quality and regulatory compliance guidance for global market requirements
• Support CAPA efforts and apply Six Sigma methodologies for problem-solving
• Drive quality assurance , process controls , and statistical analysis to meet or exceed product quality standards

Required Skills & Qualifications

• BE Mechanical Engineering with experience in medical device industry
• Strong knowledge of Quality Management Systems (ISO 13485) and Risk Management (ISO 14971)
• Familiarity with regulatory standards : CFR 820, ISO 60601
• Hands-on experience in risk management , post-market surveillance , and complaint handling
• Skilled in quality tools : Six Sigma, FMEA, FTA, DOE
• Proficient in GD&T , statistical analysis , and tools like MATLAB , MINITAB
• Preferred: CQE certification , experience with MS Project

Locations : Pune | Gurgaon

Experience : 610 years

Qualification : BE in Mechanical Engineering (Medical Device experience mandatory)