Customer Quality Engineer — 8D, CAPA & Change Control

Unisteel Technology (M) Sdn Bhd; Gelang Patah; On-site; MYR 60,000 - 90,000; Full time

Job summary

Unisteel Technology (M) Sdn Bhd is seeking a Customer Quality Engineer to act as the primary quality liaison for designated customers. You will establish inspection and control plans for medical components based on customer specs and drive containment actions for SCAR/RTV events.

You will lead 8D-based root cause investigations, coordinate cross-functional teams for CAPA, and monitor feedback from both customer and internal inspections to ensure timely improvements.

Qualifications

• Root cause analysis and problem-solving skills.
• Structured investigation using 8D methodology.
• Containment actions to limit impact of non-conformities.
• CAPA process to address root causes and prevent recurrence.
• PFMEA knowledge to assess process risks.
• Documentation controls and records management.

Responsibilities

• Act as the single quality contact for assigned customer accounts.
• Establish inspection plan and control plan for medical components based on customer specification requirements.
• Respond to customer SCAR and RTV - provide containment, root cause analysis, corrective and preventive actions and ensure its effectiveness.
• Lead structured root cause investigation using 8D methodology.
• Track on-time feedback to the front-end process based on defects detected by customer and internal inspection.
• Work with various departments for continuous improvement and conduct root cause analysis.
• Ensure documentation system is up to date (PMP, PFMEA, Work Instruction etc.).
• Own the customer change notification - screen all process, material, tooling and supplier changes against customer requirement prior to shipment.
• Ensure Quality Agreement requirement is understood, deployed and evidenced at plant level.
• Review lot record / DHR and release product with Certificate of Conformance to customer.

Skills

Root Cause Analysis

8D Methodology

Containment Actions

CAPA Process

PFMEA Knowledge

Quality Documentation

Job description

Unisteel Technology (M) Sdn Bhd is seeking a Customer Quality Engineer to act as the primary quality liaison for designated customers. You will establish inspection and control plans for medical components based on customer specs and drive containment actions for SCAR/RTV events.

You will lead 8D-based root cause investigations, coordinate cross-functional teams for CAPA, and monitor feedback from both customer and internal inspections to ensure timely improvements.