Mohammed Shaik Email & Phone Number

London, On, Ca

Skokie, Illinois, United States

Quality Assurance professional with a proven record in planning, implementing and monitoring technology solutions with a diverse background in FDA regulations, ISO guidelines, medical device validation, Project Management, validation and verification of CRM, ERP, MES, SaaS and SAP systems.Admin and Power User certification from Kneat, bolstering proficiency in managing Automation processes within the platform..• Generated comprehensive test plans, test cases, and supported the… Show more Quality Assurance professional with a proven record in planning, implementing and monitoring technology solutions with a diverse background in FDA regulations, ISO guidelines, medical device validation, Project Management, validation and verification of CRM, ERP, MES, SaaS and SAP systems.Admin and Power User certification from Kneat, bolstering proficiency in managing Automation processes within the platform..• Generated comprehensive test plans, test cases, and supported the development of test strategies, integrating CQV protocols.• Planned, implemented, and monitored technology solutions to automate various technical operations.• Developed, tested, and implemented software tools and programs to streamline processes and enhance efficiency.• Wrote scripts to automate testing and deployment processes, reducing manual effort and minimizing errors.• Designed automated systems for medical diagnostics and patient management, contributing to improved healthcare delivery.• End to end Change Control process on Service Now and Remedy tools.• Managed the AMS (Application Management System) team of 6 members in providing technical support for the application.• Conducted validation activities for medical device software and hardware components.• Was responsible for the development and implementation of Quality related processes and update of the application on a quarterly basis.• Maintenance of SDLC and Validation deliverables as per the IEC 62304 standards.• Perform Functional and Non-functional testing including integration, exploratory, API, performance, regression testing.LabWare LIMS, Veeva Vault (LMS, RIMS, QMS, QDocs, eTMF), SharePoint EDMS, Argus Safety.• Involved in developing and reviewing Computer System Validation deliverables: Validation Plan, Overall risk assessment, Review of User and Functional requirements specification documents, 21 CFR Part 11 Assessment, Detailed Risk Assessment, IQ, OQ and PQ test cases. Show less

Jacksonville, Florida, United States

Minnesota, United States