Udruth Jella

About Udruth Jella

Sound knowledge of FDA, ISO (13485 & 14971) regulations, IEC (60601, 62304), Six Sigma, Quality, CE compliance and CFR Part 820 Good Manufacturing Practice (GMP).• Knowledge of product life cycle, Risk Management System, Process Validation (IQ, OQ, PQ).• Hands on experience in production builds, testing and installation at customer sites.• Developed and maintained NCR, SCAR Matrix and used them in Trend Analysis.• Experience in handling CAPA related issues, conducting Root Cause Analysis, and closing Nonconformance Report (NCR).• Working knowledge of using: Arena (eQMS) for ECO release and Database management, ERP system for production builds, and inventory control and QuickBase.• Successfully developed, maintained BOMs, DHR (travelers), logs.• Using Hazard Analysis, developed & maintained pFMEA and equipment validation matrix.• Knowledge of creating test procedures, work instructions, SOPs, & DOPs.• Experience in inventory management with risk-based approach• Experience in working with CMOs & CDOs.• Experience in supporting internal & external audits.• Proficiency in Solidworks, EPDM, Microsoft Office, NetSuite

Experience

1. Principal Manufacturing Engineer

   Medtronic

   Dec 2025 — Present · Danvers, MA, US

Education

• Jawaharlal Nehru Technological University

  Bachelor’s Degree, Mechanical Engineering

  2010 — 2014

• University of Bridgeport

  Master’s Degree, Mechanical Engineering

  2014 — 2016