Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic

Hew Yen Xin

QA Assistant Manager
Kuala Lumpur

Summary

As a dedicated Quality Assurance Assistant Manager with more than 10 years of experience in manufacturing, I'm passionate about building strong quality systems, reducing defects, and ensuring consistent compliance with ISO standards.


My role bridges the gap between operations, customer requirements, and regulatory expectations—delivering products that are right the first time, every time. I specialize in driving continuous improvement, managing internal and external audits, and leading cross-functional teams in root cause analysis and corrective actions. With hands-on experience in FMEA, CAPA, SPC, and Lean tools, I help organizations reduce rework, improve process control, and enhance customer satisfaction.


I believe that quality is not just a department—it's a mindset. I enjoy working closely with production, engineering, and customers to embed that mindset into our culture.


Overview

14
14
years of professional experience
14
14
Certifications
3
3
Languages

Work History

Health And Safety Coordinator

Zeito Plastic Components Sdn Bhd
06.2023 - Current
  • -Coordinate and lead Emergency Response Team (ERT) and fire drills
  • -Perform risk assessments (HIRARC) and implement control measures
  • -Maintain and review safety documents, including SOPs and risk registers
  • -Liaise with DOSH officers for inspections and statutory submissions (JKKP 6/8, CHRA)
  • -Organize toolbox talks, safety awareness campaigns, and safety committee meetings
  • -Investigate incidents/near misses and ensure corrective actions are taken
  • -Yearly Plan for health and safety committee and ERT Team's Training
  • Skills: Hazard Identification, Risk Assessment and Risk Control
  • Chemical Handling, Storage and Safe Lifting
  • Fire Safety
  • Hearing Tests
  • Emergency Preparedness
  • Emergency Planning

QA Assistant Manager

Zeito Plastic Components Sdn Bhd
11.2021 - Current
  • -Lead daily QA activities and support production teams on quality-related issues
  • -Monitor and improve internal quality KPIs (customer complaints)
  • -Conduct internal audits and manage external audit preparation (ISO, customer audits)
  • -Perform root cause analysis and implement corrective/preventive actions (8D, 5 Why)
  • -Collaborate with suppliers and customers on quality feedback and improvement actions
  • Skills: 8D Problem Solving
  • 21 CFR Part 820/QMSR
  • Experience in ISO 13485
  • SWOT analysis
  • Experience in ISO 9001
  • Seven Habits of Highly Effective People
  • EN ISO 14971 Risk Management
  • Dimensional Metrology
  • Acceptance Sampling
  • Effective Root Cause Analysis
  • ISO 13485 and ISO 9001 Internal Auditing
  • Basic & Advance Training of GOM Software (3D Scan)
  • Geometric Dimensioning & Tolerancing
  • NCR/CAPA/Complaint Handling

Health and Safety Committee Deputy Chairman

05.2020 - Current
  • -Act as liaison between workers and management regarding safety concerns
  • Skills: Incident Reporting
  • Effective Safety & Health Committee
  • Lock Out Tag Out

Kaizen Team Member

01.2020 - 12.2023

Sr Project Engineer

06.2019 - 10.2021
  • Skills: Coordinating Schedules
  • Technical Drawing
  • Project Management
  • Molding (Process)
  • Customer Experience
  • Process Validation

Production Assistant Manager

Jinhui Industries Sdn Bhd
07.2018 - 07.2019
  • Skills: Customer Service
  • Request for Quotation (RFQ)
  • Production Schedules
  • Purchase Orders
  • China Manufacturing
  • Production Management

Engineer

Jinhui Industries Sdn Bhd
09.2011 - 06.2018
  • Skills: Mechanical Product Design
  • Measurement Jig Design
  • Mechanical Troubleshooting
  • AutoCAD
  • Computer-Aided Design (CAD)
  • Fixture Design
  • Tolerance Design
  • Internal Audits
  • Bill of Materials (BOM) Creation

Education

Bachelor of Science - Mechanical Engineering

University Tenaga Nasional
Bangi, Selangor, Malaysia
04.2001 -

Skills

  • Bill of Materials (BOM) Creation
  • Emergency Preparedness
  • Emergency Planning
  • Hearing Tests
  • Fire Safety
  • SWOT analysis
  • Lock Out Tag Out
  • Hazard Identification, Risk Assessment and Risk Control
  • Effective Safety & Health Committee
  • Incident Reporting
  • Basic & Advance Training of GOM Software (3D Scan)
  • Process Validation
  • Chemical Handling, Storage and Safe Lifting
  • Health And Safety Coordinator
  • Geometric Dimensioning & Tolerancing
  • Dimensional Metrology
  • 8D Problem Solving
  • Acceptance Sampling
  • 21 CFR Part 820/QMSR
  • Customer Service
  • Purchase Orders
  • Request for Quotation (RFQ)
  • China Manufacturing
  • ISO 13485 and ISO 9001 Internal Auditing
  • Mechanical Product Design
  • Fixture Design
  • Measurement Jig Design
  • Tolerance Design
  • Mechanical Troubleshooting
  • Internal Audits
  • Production Schedules
  • Production Management
  • Effective Root Cause Analysis
  • EN ISO 14971 Risk Management
  • NCR/CAPA/Complaint Handling
  • Customer Experience
  • Technical Drawing
  • Molding (Process)
  • Coordinating Schedules
  • Experience in ISO 13485
  • Experience in ISO 9001
  • Troubleshooting and analysis
  • AutoCAD
  • Microsoft Office
  • Project Management
  • Microsoft Word
  • Mechanical Engineering
  • Computer-Aided Design (CAD)
  • Microsoft PowerPoint

Certification

Long Service Award

Timeline

Health And Safety Coordinator

Zeito Plastic Components Sdn Bhd
06.2023 - Current

QA Assistant Manager

Zeito Plastic Components Sdn Bhd
11.2021 - Current

Health and Safety Committee Deputy Chairman

05.2020 - Current

Kaizen Team Member

01.2020 - 12.2023

Sr Project Engineer

06.2019 - 10.2021

Production Assistant Manager

Jinhui Industries Sdn Bhd
07.2018 - 07.2019

Engineer

Jinhui Industries Sdn Bhd
09.2011 - 06.2018

Bachelor of Science - Mechanical Engineering

University Tenaga Nasional
04.2001 -
Hew Yen XinQA Assistant Manager