Hew Yen Xin
Assistant Quality Assurance Manager @ Zeito Plastic Components Sdn Bhd
About
Results-driven Quality Assurance professional with over 10 years of experience in manufacturing, specializing in Integrated Management Systems (IMS) compliance across ISO 9001, ISO 13485, and ISO 14001. Proven success in quality system management, supplier development, and continuous improvement, with strong leadership in process control, audit management, and customer satisfaction. Recognized for strengthening safety culture, driving regulatory compliance, and building effective cross-functional collaboration between QA, Production, and Engineering teams. At the same time, I am also a committed and proactive Safety Coordinator with hands-on experience in managing workplace safety, health, and compliance in manufacturing environments. I support companies in creating a safer workplace through hazard identification, risk assessments, safety training, and ensuring compliance with OSHA (Act 514), FMA 1967, and DOSH Malaysia requirements. I also assist in conducting emergency response drills, preparing safety documentation, and engaging with employees to build a strong safety culture. I believe that safety is everyone's responsibility, and I work to empower teams to take ownership of their environment through awareness, training, and continuous improvement.
Malaysia
WP. Kuala Lumpur
Mechanical Or Industrial Engineering
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, Seven Habits of Highly Effective People, Effective Safety & Health Committee , Incident Reporting, Basic & Advance Training of GOM Software (3D Scan), Process Validation, Chemical Handling, Storage and Safe Lifting, Geometric Dimensioning & Tolerancing, Dimensional Metrology, 8D Problem Solving, Acceptance Sampling, 21 CFR Part 820/QMSR, Customer Service
Experience

Assistant Quality Assurance Manager
Selangor, Malaysia
-Lead daily QA activities (over 40 QA personnel) 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 Key Achievements: -Reduced customer complaints through robust CAPA and root cause analysis initiatives. -Successfully led multiple third-party and customer audits with zero major findings. -Established a Skill Matrix framework that mapped over 40 employee skill sets, enabling data-driven training plans, reducing task assignment errors, and increasing team flexibility by 25% -Conducted time studies, identifying process inefficiencies, and propose improvement plan with ROI study. -Reduced man-hours by 80% using digitized inspection workflows, transitioning from manual hardcopy inspection form to integrated software and softcopy formats, improving traceability and reducing paper usage. -Successfully reduced production rejection by 30% using comprehensive data collection, liaised with multiple stakeholder follow with data driven root cause analysis.

Health And Safety Coordinator
Selangor, Malaysia
-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 (1st aid training, Fire Safety, etc) Key Achievements: - Reduce 5% accident in yearly basis over 3 years time - Organized Blood Donation - Organized Health Check - Successfully strengthened forklift safety control by certifying an in-house trainer, upgrading training materials and work instructions, introducing mandatory practice hours, and enforcing stricter disciplinary actions, including license forfeiture for repeat accident offenders

Sr Project Engineer
-Led and coordinated full-cycle plastic injection molding projects from initial customer RFQ through to mass production readiness. -Translated customer requirements into technical specifications and worked with cross-functional teams including QA, production, and tooling to ensure timely and quality-focused project delivery. -Oversaw DFM (Design for Manufacturability) reviews, mold trial evaluations, and validation activities (IQ, OQ, PQ) for medical and industrial components. -Managed project schedules, resource planning, and communication with customers to ensure alignment on deliverables and timelines. -Delivered engineering support in troubleshooting molding issues, refining parameters, and improving cycle time and part quality. -Prepared technical documentation including control plans, inspection plans, and process flow diagrams. -Feedback drawing technical issue/concern to customer Key Achievements: -Successfully launched new projects with zero major quality issues during initial ramp-up within 4 months.

Production Assistant Manager
Jinhui Industries Sdn Bhd
-Oversaw daily production operations for plastic and metal components, ensuring timely delivery, product quality, and resource efficiency, especially item from China. -Coordinated manpower allocation, machine utilization, and production schedules to meet sales team deadlines -Supervised production operators and line leaders, ensuring adherence to safety, quality, and work instruction protocols.

Engineer
Jinhui Industries Sdn Bdh
-Focusing on design improvement, manufacturability, and production efficiency. -Created and maintained detailed technical drawings, including mechanical part designs, fixture concepts, and measurement jigs using AutoCAD and CAD tools -Determine tolerance with GD&T application to ensure component compatibility and precision assembly. -Supported internal audits, corrective actions, and quality control measures to align with ISO 9001 requirements. -Gained exposure to welding, CNC machining, stamping, bending, sawing and coating processes. -Provided hands-on troubleshooting of mechanical issues during manufacturing to reduce downtime and improve yield. Key Contributions: -Designed and implemented customized measurement jigs/Fixture that improved inspection efficiency by 20%. -Designed and implemented substitute component that achieve cost reduction by 10% -Designed and implemented customized welding jigs that reduce production rejection by 30%
Hew Yen Xin's Contact Information
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