Shashank HM

• Over 10 years of experience as Technical Test Lead in FDA regulated medical device and financial services, capital market industries. • Certified Scrum Master by Scrum Alliance • Extensive knowledge in QA Processes, Testing Methodology, Defect Management, and Test Estimation and Planning. • Expertise in designing and developing test strategy, test plan, test cases, generating test reports, defect reports and product quality assurance documentation. • Communicate with developers, System engineers, business analysts, Product managers and Clinical specialists who are involved in application design and document reviews. • Excellent verbal and written communication skills, ability to interact professionally with a diverse group, executives, managers, and subject matter experts. • Knowledge of ISO 13485 standard and FDA’s Title 21 CFR Part 820, which are applicable for Medical devices Quality Management system. • Knowledge of Automation tools like QTP, Coded UI, Cucumber tests. • Expertise with Boundary value analysis, Equivalence partitioning, and Error guessing techniques, Smoke, Functional, Regression, Beta testing, Database, and Integration testing. • Hands-on experience writing complex SQL queries and a basic understanding of DWH concepts. • Experience in implementing SDLC methodologies including Waterfall Model and Agile methodology.