Summary
Overview
Work History
Education
Skills
Timeline
Generic

I Mo

Charlotte,NC

Summary

Results-driven Software Quality Engineer with extensive experience at Argon Medical, specializing in validation protocols and risk assessments. Proven expertise in FDA compliance and ISO 13485 standards, coupled with strong collaboration skills. Successfully executed IQ, OQ, and PQ protocols, enhancing software robustness through rigorous performance testing and change control processes.

Overview

9
9
years of professional experience

Work History

Software Quality Engineer

Argon Medical
Athens, TX
12.2022 - Current
  • Developed and executed validation deliverables (IQ, OQ, PQ, URS, FRS) ensuring compliance with FDA and ISO 13485.
  • Performed software risk assessments, CAPA investigations, and implemented mitigation strategies.
  • Conducted post-market surveillance, defect tracking, and ensured validated state through change control.
  • Supported audits, authored validation reports, SDHF files, and collaborated with QA, IT, and regulatory teams.
  • Conducted performance, load, and stress testing to evaluate software robustness.

Computer System Validation Engineer

Lonza
TX
07.2020 - 11.2022
  • Executed validation protocols (IQ, OQ, PQ) for Veeva Vault, LIMS, MES, Empower, and ERP systems.
  • Authored and reviewed Validation Plans, Test Plans, URS, FRS, Risk Assessments, SOPs, and Traceability Matrices.
  • Conducted change control, CAPA, and defect investigations ensuring audit readiness.
  • Collaborated with cross-functional teams to enhance validation processes and data integrity controls.
  • Supported internal and external audits, ensuring compliance with FDA 21 CFR Part 11 and Annex 11.

Computer System Validation Analyst

Formonex Solutions
Hyderabad, India
01.2018 - 03.2019
  • Supported validation and change control processes for Oracle-based systems and customer applications.
  • Authored test plans, risk assessments, and recovery plans, ensuring compliance with GxP standards.
  • Conducted load/performance testing and monitored system performance with HP LoadRunner.
  • Collaborated with developers, QA, and compliance teams to ensure defect resolution and validated state.

Computer System Validation Specialist

Reddy Labs
India, India
06.2016 - 12.2017
  • Drafted and executed IQ, OQ protocols for regulatory applications, ensuring FDA compliance.
  • Managed validation documentation in Aegis EDMS and TrackWise for audit readiness.
  • Conducted risk assessments, CAPA, and change control for system upgrades and maintenance.
  • Ensured compliance with electronic records and signature requirements (21 CFR Part 11).

Education

Master of Science - IT Management

Texas A&M University
Kingsville, TX
05-2016

Bachelor's - Electrical Engineering

JNTU Hyderabad
Hyderabad, India

Skills

  • Validation Plans
  • Test Plans
  • URS
  • FRS
  • SRS
  • Risk Assessments
  • IQ
  • OQ
  • PQ Protocols
  • Traceability Matrices
  • Validation Summary Reports
  • SOPs
  • CAPA
  • Change Control
  • FDA 21 CFR Part 11
  • CGMP
  • GAMP 5
  • ISO 13485
  • ISO 27001
  • Annex 11
  • IEC 62304
  • Quality Center (HP ALM)
  • JIRA
  • TrackWise
  • ComplianceWire
  • Veeva Vault
  • Aegis EDMS
  • SharePoint
  • DOORS
  • SAP
  • SQL
  • MS Visio
  • MS Project
  • Functional Testing
  • Integration Testing
  • UAT
  • Performance Testing
  • Load Testing
  • Stress Testing
  • LIMS
  • EDMS
  • CTMS
  • ETMF
  • MES
  • Empower
  • ERP
  • Oracle-based apps
  • Cloud (SaaS, IaaS, PaaS)

Timeline

Software Quality Engineer

Argon Medical
12.2022 - Current

Computer System Validation Engineer

Lonza
07.2020 - 11.2022

Computer System Validation Analyst

Formonex Solutions
01.2018 - 03.2019

Computer System Validation Specialist

Reddy Labs
06.2016 - 12.2017

Master of Science - IT Management

Texas A&M University

Bachelor's - Electrical Engineering

JNTU Hyderabad

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