A proven leader with 16 Years of experience in Quality, Test Automation, People management/Team lead, best practices, Agile. Ability to establish processes and systems meeting Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820, ISO 13485, ISO 14971 requirements and other related regulations with emphasis in CAPA Systems. Experience in Medical Device compliance in accordance with FDA 21 CFR Part 820, IEC 62304 etc. Understanding of risk analysis and root cause analysis in the context of ISO 14971. Proven leader, able to work with limited supervision. Excellent communication and collaboration abilitiesDomains Expertise:• Healthcare Domain ISO 9001, ISO 13485, IEC 62304 etc.• Financial Domain• Design controls• Process validationProven ability in dealing with the following:• Managed technical staff of 12+ (in house and offshore), software engineers and test automation engineers on multiple teams.• System procedures as required (e.g., SOP's, protocols, and reports).• Software Development and Testing Life Cycle (SDLC\STLC) for both Client/Server and Web-based applications.• Collaborated with cross-functional teams to establish and enforce product quality specifications, ensuring consistency and adherence to brand standards. • Conducted regular product quality inspections/tests and drove investigations into any deviations from established standards.• Process Review and Defect Prevention activities with all relevant testing concepts and methodologies.• Automation testing using Selenium, SpecFlow+ and Selenium Automation tool.• Well versed with Agile and Scrum based working Process.• Aggressively identified and managed activities related to adding value to the organization through the planning, implementation, and optimization of the quality management system.• Lead, oversee or participated in multiple portions of the Quality System, including but not limited to Management Review, Internal Audit, Audit Readiness, NC/CAPA, Document Control, Training.Technical Proficiency:1. Manual/Test Automation (Selenium, Specflow+, BDD, C#, Python), CI CD Integration, setting up automation build agents for CI/CD.2. Platform - Windows 10, Windows Server, MAC.3. Tools - Oracle Cloud and Azure Dev Ops/Visual Studio 2022, MS Test Manager, HP Quality Center, Team Foundation Server, Bugzilla, Microsoft SQL Server, Mantis, CodedUI. ALM, Browserstack, TestIM, Tricentis Mobile.4. Performance Testing - Visual Studio Web Performance and Load Test Tool. JMeter