Arun J M

Led design quality activities for Class II medical devices in compliance with ISO 13485, FDA, and EU MDR requirements. Supported design controls, including design reviews, risk management, DHF documentation, traceability, and engineering change control. Developed and executed verification and validation protocols and reports for electromechanical and fluidics-based medical devices. Performed process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Perf

Supported design teams with feedback and validation insights. Supported verification and validation activities throughout the product development lifecycle. Developed requirements-based test cases and maintained traceability using RTM. Assisted with defect investigations, root cause analysis, and nonconformance resolution. Improved test documentation to enhance compliance and audit readiness. Contributed to process improvement and automation initiatives.