Job Description
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
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
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