Incoming Quality Engineer

Masimo.; Pasir Gudang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Masimo is seeking an Incoming Quality Engineer to ensure incoming materials and components meet quality standards, regulatory requirements, and manufacturing specifications. This role performs inspections, maintains documentation, supports supplier quality improvements, and drives continuous improvement across the supply chain.

You will drive quality system activities, participate in internal audits, calibrate inspection equipment, and train teams on compliant incoming inspection processes.

Qualifications

• Bachelor’s degree in Engineering or a related field.
• Minimum 3 years of experience in Incoming Quality or Quality Engineering in manufacturing.
• Experience with quality inspection using measuring tools, microscope, and image measuring systems.
• Knowledge of root cause analysis, CAPA, risk management and quality improvement tools.
• Strong analytical and communication skills; proficient in English.
• Experience with Microsoft Office applications.

Responsibilities

• Perform incoming inspection of materials and components to quality standards.
• Review and maintain quality records, inspection reports, COC, and documentation.
• Identify and manage non-conforming materials and support CAPA actions.
• Collaborate with suppliers and internal teams to resolve quality issues.
• Ensure proper use of quality documentation and inspection procedures at point of use.
• Support quality system activities including internal audits and document control.
• Maintain inspection equipment calibration and ensure compliance with requirements.
• Participate in continuous improvement projects to enhance product quality.
• Provide training and guidance on incoming inspection processes and standards.

Skills

Quality inspection

CAPA

Root cause analysis

Supplier quality

Analytical skills

Education

Bachelor's Degree in Engineering or related field

Tools

Measuring tools

Microscope

Image measuring systems

Job description

We are seeking an Incoming Quality Engineer to ensure incoming materials and components meet quality standards, regulatory requirements, and manufacturing specifications. This role is responsible for performing inspections, managing quality documentation, supporting supplier quality improvement, and driving continuous improvement initiatives within the supply chain.

Job Summary

We are seeking an Incoming Quality Engineer to ensure incoming materials and components meet quality standards, regulatory requirements, and manufacturing specifications. This role is responsible for performing inspections, managing quality documentation, supporting supplier quality improvement, and driving continuous improvement initiatives within the supply chain.

Key Responsibilities

• Perform incoming inspection of materials and components according to quality standards and specifications.
• Review and maintain quality records, inspection reports, COC, and related documentation.
• Identify and manage non-conforming materials and support corrective actions (CAPA).
• Collaborate with suppliers and internal teams to resolve quality issues and improve material quality.
• Ensure proper use of quality documentation, inspection procedures, and visual aids at point of use.
• Support quality system activities including internal audits, document control, and quality reporting.
• Maintain inspection equipment calibration and ensure compliance with quality requirements.
• Participate in continuous improvement projects to enhance product quality and operational efficiency.
• Provide training and guidance on incoming inspection processes and quality standards.

Requirements

• Bachelor’s Degree in Engineering or related field.
• Minimum 3 years of experience in Incoming Quality or Quality Engineering within a manufacturing environment.
• Experience in quality inspection using measuring tools, microscope, and image measuring systems.
• Knowledge of root cause analysis, CAPA, risk management, and quality improvement tools.
• Strong analytical, problem-solving, and communication skills.
• Good English communication skills (written and spoken).
• Proficient in Microsoft Office applications.

Added Advantage

• Experience in medical device manufacturing and knowledge of ISO 13485, ISO 14971, IEC 60601-1, and FDA requirements.
• Certified ISO Internal Auditor.
• Knowledge of statistical analysis and quality management systems.