• Design Verification testing execution with respect as design verification protocol and test methods.• Creating / Testing /Performing Validation activities like IQ/OQ/PQ for Medical devices and analyze the results through Minitab software.• Representing data periodically in CAPA review board meetings.• Root cause analysis through problem solving tools like Six sigma, SPC, FMEA, MSA for NCMR and NCPR. • Worked on SCAR with Supplier quality assurance.• Knowledge in DHF and DMR contents are compliance to Regulatory and ISO Standards.• Trained for standards ISO 13485:2016, ENISO 14971-2019, ISO 9001:2015, EU MDR2017/745, ISO 17665-1:2006, ISO 3826-4:2015, 21 CFR 820. • Equipment software qualification for Mechanical properties testing machine such Instron UTM, Test resources UTM, OGP video measurement machine, climate chamber, IDTE and other Hydraulic burst leak tester. • Worked Value improvement projects to save resource time and Equipment downtimes. Analyzed equipment usage data and equipment health and changed the frequency of PM and Calibration of equipments.• New Product development activities like developing precision Electromechanical prototype assemblies, CAD drawing review, Design documentation and Manufacturing Quality Assurance.Validation Engineering ❖ Performing Installation Qualification(IQ) ❖ Performing Operational Qualification(OQ) ❖ Performing Performance Qualification(PQ) ❖ Performing Test Method Validation ❖ Process characterization for Equipment validation ❖ Analysis Gauge R&R, Regression analysis, Attribute analysis. ❖ Performing FAT / SAT for Medical and other equipment’s ❖ Performing IQ, OQ & PQ for Steam sterilizer and ETO sterilizer. ❖ Engineering Change order process for all product and Equipment’s.Manufacturing Engineering ❖ Drafting 2D drawing from Part modelling. ❖ GD&T for 2D part drawing. ❖ Supplier evaluation and Supplier CAPA analysis ❖ Create SOP for process and product manufacturing.