Design Quality Assurance - Medical Devices

About the RoleJoin 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 ResponsibilitiesLead product risk management, usability, reliability, and design validation for new product development and design changesDevelop and implement design verification & validation plans with project design leadsDefine Critical to Quality (CTQs), design input/output documents, and ensure adherence to quality systems & SOPsManage fixture qualification, test method validation, and electronic document controlConduct FMEA sessions, DOE, risk management, and ensure compliance with CTQs and safety requirementsProvide quality and regulatory compliance guidance for global market requirementsSupport CAPA efforts and apply Six Sigma methodologies for problem-solvingDrive quality assurance, process controls, and statistical analysis to meet or exceed product quality standardsRequired Skills & QualificationsBE Mechanical Engineering with experience in medical device industryStrong knowledge of Quality Management Systems (ISO 13485) and Risk Management (ISO 14971)Familiarity with regulatory standards: CFR 820, ISO 60601Hands-on experience in risk management, post-market surveillance, and complaint handlingSkilled in quality tools: Six Sigma, FMEA, FTA, DOEProficient in GD&T, statistical analysis, and tools like MATLAB, MINITABPreferred: CQE certification, experience with MS Project

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