Geethanjali Ramesh

About Geethanjali Ramesh

A multi- skilled professional with a record of managing projects in various segments and…

Experience

1. Medical Qms Program Manager

   Amazon

   Mar 2022 — Present

   Led multiple product change requests by collaborating with product, quality, and regulatory teams to assess the risk/impact, secure approval, and monitor implementation considering the business and regulatory submission time lines (working backwards approach).\\\\nProvided Quality support for product regulatory submissions, approval and launch readiness by following Product Development Process.\\\\nEstablished and handled Quality Design History File (DHF) documentation timelines working with multiple cross-functional teams.\\\\nLead Weekly/Monthly/Quarterly Business review meeting for Medical Device Operational Compliance Center (MD-OCC) to provide status update on Quality process performance, Program related Quality, Quality Improvement Projects.\\\\nLed Change Management, Non-conformance, Corrective and Preventive Action, Management Reporting, Data Analysis, Document and Record control processes with a cross-functional team to ensure compliance with regulatory requirements and optimize process efficiency.\\\\nDeveloped user requirements and supported to build Matrix - electronic Quality Management system for CAPA process\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Education

• Northeastern University - Seattle

  Master of Science (MS), Project Management

  2016

• PSG College of Technology

  Diploma, Electrical and Electronics Engineering

  2006 — 2009

• PSG College of Technology

  Bachelor of Engineering (BE), Biomedical/Medical Engineering

  2009 — 2012

Skills

• Testing
• Budgeting
• Project Coordination
• Leadership
• Communication
• Team Management
• Scheduling
• Quality System
• Fda
• Internal Audit
• Negotiation
• Medical Devices
• Capa
• Analytics
• Biomedical Engineering
• Program Management
• Project Management
• Supplier Quality Management
• Fda Gmp
• Quality System Compliance
• Microsoft Project
• Ms Project
• Quality Management
• Quality Assurance
• Engineering
• Project Planning
• Regulatory Affairs
• Ms Excel
• R
• Risk Management
• Iso 13485
• Organization Skills
• Quality Control
• Medical Imaging
• Microsoft Office
• Manufacturing
• Gmp