Raquel Tan
Yardley,Pennsylvania
Summary
Validation and compliance-focused Quality Specialist with 16+ years in FDA- and cGMP-regulated manufacturing environments. Proven success in software and equipment validation (IQ/OQ/PQ), audit readiness, and CAPA execution across medical device and manufacturing sectors. Skilled in risk assessment, defect analysis, and cross-functional collaboration to ensure regulatory alignment and system reliability. Adept at supporting validation protocol development, managing documentation, and driving continuous improvement in support of inspection readiness and data integrity.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Advanced Software Quality Analyst
Syncro Medical
02.2019 - Current
- Contributed to validation and manual testing of Boston Scientific cardiac medical equipment software in compliance with FDA and cGMP standards
- Supported development and execution of URS, IQ, OQ, and PQ protocols; verified installation, calibration, and environmental conditions
- Participated in risk assessments, technical evaluations, and CAPA investigations for system changes and deviations
- Developed automated test scripts using Playwright and Python for UI and workflow validation
- Designed traceable test cases in PyCharm and JAMA; tracked defects in Jira
- Collaborated with PMs, Tech Leads, and QA to align validation deliverables with project timelines
- Assisted in commissioning and qualification of software systems and test environments
- Trained new engineers on validation protocols, tools, and system workflows
Business Process Manager
Direct With Hotels
08.2007 - 01.2008
- Documented business processes for ISO 9001 certification
- Facilitated cross-departmental process improvement workshops and established performance metrics
Quality Control Officer / QISMS Manager
SPi Global
05.2003 - 08.2007
- Managed ISO 9001 and ISO 27001 internal audit programs; developed and mentored internal auditors
- Led Six Sigma and PDCA-based improvement projects; conducted gap assessments and risk analyses
- Supported client audits across business units, ensuring compliance and increasing project awards
Quality Control Engineer / Line Leader
Toshiba Information Equipment Phils.
06.2000 - 05.2003
- Led, organized, and supervised production quality operators, ensuring alignment with productivity targets, quality standards, schedules, and client requirements
- Supervised subcontractor lines and led new model transitions for PCB manufacturing
- Conducted line audits, defect evaluations, and 8D problem-solving for customer complaints
- Delivered training on ISO 14000, KAIZEN, and 5S; developed SOPs to standardize procedures
- Certified ISO 9001 Internal Auditor; conducted internal and supplier audits
Quality Control Staff
Best Chemical and Plastics Inc.
03.1999 - 03.2000
- Performed physical and chemical inspections of film products
- Built sampling plans and implemented CAPAs based on customer feedback
Education
Bachelor of Science - Chemical Engineering
Mapúa Institute of Technology
Manila, Philippines04-1998
Skills
- Validation lifecycle execution (IQ/OQ/PQ)
- Risk assessment, defect analysis, technical writing
- Audit readiness and compliance validation
- Process mapping and improvement facilitation
- Cross-functional collaboration and team leadership
- Documentation accuracy and attention to detail
Certification
- Certified ISO 9001 Internal Quality Auditor – Toshiba
- Certified Six Sigma Project Leader – Toshiba
- Certified Six Sigma Black Belt – QAI India Ltd.
- Certified Six Sigma Green Belt – QAI India Ltd.
Timeline
Advanced Software Quality Analyst
Syncro Medical
02.2019 - Current
Business Process Manager
Direct With Hotels
08.2007 - 01.2008
Quality Control Officer / QISMS Manager
SPi Global
05.2003 - 08.2007
Quality Control Engineer / Line Leader
Toshiba Information Equipment Phils.
06.2000 - 05.2003
Quality Control Staff
Best Chemical and Plastics Inc.
03.1999 - 03.2000
Bachelor of Science - Chemical Engineering
Mapúa Institute of Technology
TOOLS
- Scripting & Automation: Python, Playwright
- Validation & Collaboration: PyCharm, JAMA, Jira, Git, Confluence
- Productivity & Reporting: MS Word, Excel (statistical reporting), PowerPoint
- Statistical & Quality Analysis: Minitab, DOE, Gage R&R, FMEA, Fishbone Diagram
COMPLIANCE FRAMEWORKS
- FDA regulations, cGMP, GDP
- ISO 9001, ISO 27001, ISO 14000
- Validation documentation lifecycle, QMS record management
- Internal and supplier audit programs
QUALITY FRAMEWORKS
- Six Sigma (Black Belt, Green Belt, Project Leader)
- PDCA Cycle (Plan–Do–Check–Act)
- Balanced Scorecard
- Business Continuity Planning (BCP)