Senior Test Manager
CurrentI am working as a test manager on multiple levels within the organization. Primary product type in my scope is medical device software.My responsibilities includes- Product owner for a group of testers working with test automation- Key stakeholder for test in an ongoing department wide SAFe transformation- Heavily involved in the transition to MDR compliance from MDD for medical software- Planning and analyzing the test need of the product / component / platform I am responsible for- Devising means to improve the testing process- Creating test strategies that adhere to the company policies for quality- Aligning verification approach and documentation for products to comply with medical device standards - especially EN IEC 62304 and FDA CFR 21 part 820- Creating the final verification and validation reports for both products and platforms for regulatory purposes (MDR, FDA and MDSAP primarily)Tools usedIBM RQM and DOORsAtlassian Jira Align, Jira and ConfluenceMicrosoft TFS, Visual Studio and MTM