Tarun Krishna

About Tarun Krishna

Highly skilled Quality Systems engineer with 6+ years of experience in manufacturing, production, quality, writing protocols for validation, planning and control. Ability to lead a team towards the prescribed goal. Experience in Quality Engineering, QMS, Lean Manufacturing, Process Improvement, CAPA Management, New Product Process Verification & Validation, Risk Management and Quality Assurance in compliance with FDA regulations.

Experience

1. Lead Process Engineer

   Gionee Medical

   Oct 2023 — Present · Duluth, MN, US

   Responsible for conducting continuous improvement to improve processes and product quality, production processes, to improve outgoing yieldConducted comprehensive Process Validation activities to ensure production processes consistently meet predetermined specifications and quality attributes. This included developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in alignment with regulatory standards and industry best practices.Authored and maintained detailed Validation Protocols and Reports, outlining objectives, scope, methodology, acceptance criteria, and documented results to support product and process integrity. Ensured that all validation documentation complied with regulatory requirements, such as FDA guidelines, ISO 13485, and ISO 14971.Applied Lean Six Sigma and Continuous Improvement concepts to eliminate waste, improve throughput, improve quality, and reduce costManaged records of CAPA activities in QMS to address identified issues.Prepared protocols and reports for IQ, OQ, PQ, and TMV & Validation Plan for remediation project.Facilitated product and process risk management activities for risk management plans, hazard analysis, dFMEAs and pFMEAs in compliance with the requirements of ISO14971

Education

• The University of Texas at Arlington

  Master's degree, Mechanical Engineering

• JNTUH College of Engineering Hyderabad

  Bachelor's degree, Mechanical Engineering