Anushaa Anbazhagan

Quality Engineer Iii @Thermo Fisher Scientific

Middletown, VA, US

As a Quality Engineer in the Clinical Diagnostics division, I drive product quality and process optimization by:Reviewing non-conformances and validating processes and equipment to ensure compliance through comprehensive pre- and post-approval assessments.Leading risk management efforts, managing dFMEA and pFMEA files, and conducting process capability studies to enhance product performance and ensure reliability.Performing Gemba walks to identify non-conformances at the shop floor level, taking proactive steps to resolve quality issues.Collaborating with cross-functional teams, including Manufacturing Engineering (ME), Technical Operations (Tech Ops), and team leads to swiftly identify and address operational challenges.Generating and analyzing quality metrics by identifying GDP errors through audits and SAP, providing actionable insights that drive continuous improvement in operational performance and ensure adherence to regulatory standards