Young Pham

About Young Pham

Core competencies:• 17 years experience in the medical device industry as a subject matter expert in software validation• Experience in FDA 483 Observation, FDA Consent Decree and FDA audits• In-depth knowledge of 21 CFR Part 820 Quality System Regulation, ISO 9001 & 13485, 21CFR Part 11 (Electronic Records & Signature), GAMP 4 & GAMP 5* Experience in developing software validation plan, system classification, risk analysis, user requirements, functional design requirements, IQ, OQ, and PQ protocols, traceability matrix, SOP, qualification summary report, and validation summary report• Experience also design control, change and configuration management• Software Development Life Cycle (Waterfall Method & Risk-based Approach)• Skilled in writing procedures, processes and work instruction• Excellent writing test report planning, protocols designing and test execution, quality assurance methodologies, regression, integration, system level, stress load testing, and bug executionSpecialties: Expertise in Software and system remediation, spreadsheet validation, equipment validation (IQ, OQ, PQ), gap analysis and electronic records & electronic signature assessment, and vendor audit.

Experience

1. Product Software Quality Engineer Consultant

   Oxford

   Feb 2019 — Present · San Jose, CA, US

Education

• San José State University

  Dual BS, MIS/Marketing

• Texas A&M University

  Master of Business Administration - MBA, Business Administration and Management, General

• East Texas A&M University

  MBA, Business Administration and Management, General

Skills

• Iso 13485
• Design Control
• Medical Devices
• Capa
• Computer System Validation
• Fda
• Validation
• Gamp
• Quality System
• V&V
• Quality Auditing
• Change Control
• Gmp
• 21 Cfr Part 11
• Quality Assurance