Quality Engineer

Toyoplas Manufacturing (Malaysia) Sdn Bhd; Kulai; On-site; MYR 60,000 - 90,000; Full time

Job summary

Toyoplas Manufacturing (Malaysia) Sdn Bhd in Kulai, Johor, is seeking a Quality Engineer to monitor and improve product quality across plastic injection molding and assembly processes for medical product components.

You will lead quality control activities, perform CAPA, support NPI, process validation, and audits, and collaborate with Production, Engineering and Maintenance to drive continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Quality Management, Manufacturing or related field.
• 2–5 years of quality engineering experience in a manufacturing environment.
• Hands-on experience with medical product assembly manufacturing is preferred.

Responsibilities

• Monitor and improve product quality in plastic injection molding and assembly processes.
• Support quality control activities for medical product assembly operations.
• Conduct product, process, and system inspections to ensure compliance with quality standards.
• Investigate quality issues, perform root cause analysis, and implement CAPA.
• Handle customer complaints and coordinate containment and corrective actions.
• Support new product introduction, process validation and production trials.
• Prepare and maintain quality documentation, reports, inspection records and work instructions.
• Ensure ISO 9001 and ISO 13485 compliance where applicable.

Skills

Quality engineering

FMEA

SPC

MSA

Control plans

CAPA

Root cause analysis

Analytical skills

Communication skills

Education

Bachelor's degree in Engineering/Quality Management

Tools

Microsoft Office

Job description

Monitor and improve product quality in plastic injection molding and assembly processes.

Support quality control activities for medical product assembly operations.

Conduct product, process, and system inspections to ensure compliance with quality standards.

Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).

Handle customer complaints and coordinate containment and corrective actions.

Support new product introduction (NPI), process validation, and production trials.

Prepare and maintain quality documentation, reports, inspection records, and work instructions.

Ensure compliance with ISO 9001, ISO 13485 (where applicable), customer requirements, and company procedures.

Work closely with Production, Engineering, and Maintenance teams to improve product quality and process capability.

Analyze quality data and drive continuous improvement initiatives.

Conduct internal audits and participate in external customer or regulatory audits.

Train production operators and inspectors on quality requirements and inspection standards.

Requirements

Bachelor's Degree or Diploma in Engineering, Quality Management, Manufacturing, or related field.

Minimum 2-5 years of experience in quality engineering within a manufacturing environment.

Hands-on experience in medical product assembly manufacturing is required.

Experience in plastic injection molding and plastic assembly processes.

Knowledge of quality tools such as FMEA, SPC, MSA, Control Plan, 8D, CAPA, and 7 QC Tools.

Familiar with ISO 9001 and ISO 13485 quality management systems.

Strong analytical, problem-solving, and communication skills.

Proficient in Microsoft Office applications.

Toyoplas Manufacturing (Malaysia) Sdn Bhd is part of the Toyoplas Group of Companies that offer customized services in plastic injection molding, turnkey projects, mold-making, the full spectrum of secondary processes such as lacquering, spray-painting, silk-screen and tempo printing, laser marking and assembly. On Group basis, we further provide aluminum die-casting and CNC machining services, SMT insertion operations and as an EMS/ODM services company, offer CAD/CAM services. In line with our continued expansion and integration of our service capabilities, we are now inviting suitable candidates to join us at our plants in Malaysia, Indonesia and China

Toyoplas Manufacturing (Malaysia) Sdn Bhd is part of the Toyoplas Group of Companies that offer customized services in plastic injection molding, turnkey projects, mold-making, the full spectrum of secondary processes such as lacquering, spray-painting, silk-screen and tempo printing, laser marking and assembly. On Group basis, we further provide aluminum die-casting and CNC machining services, SMT insertion operations and as an EMS/ODM services company, offer CAD/CAM services. In line with our continued expansion and integration of our service capabilities, we are now inviting suitable candidates to join us at our plants in Malaysia, Indonesia and China