Sushma Shanubhog Email & Phone Number

A Qualified R&D QA & QC with over 5.3 years of extensive experience and involved in all phases of Product Design & Development involving Hardware Testing, Integration Testing spanning across Healthcare Domains.Core Competencies:• Good knowledge in SDLC models•Agile •Verification and Validation•Good Knowledge to define system and subsystem testing for Clinical product.•Good Knowledge with and without radiation Medical Clinical Product testing.•Good Knowledge in Imaging component selections and testing.• Good Knowledge in System Cable assembly and testing• Good Knowledge in System Workflow of Kidney Dialysis machine and also X-Ray unit.• Good knowledge in understanding product cable assembly and testing. •Good knowledge of the medical standards•Good knowledge about regulatory requirements•Good knowledge about IEC (International Electro technical Commission) (60601-1) (60601-2), ISO (9001), ISO (13485), IEC (62304), FDA, EuMDR standards and testing like •Full manual software/ Product testing• Regression testing•Integration testing•UAT•Functional testing (end to end)•Adhoc testing•Familiarity with the tools, concepts and methodologies of quality management• Change management• JIRA tool•TFS tools•DICOM( Digital Imaging and Communications in Medicine )