Customer Quality Assurance Engineer - Medical Devices

Kanry Search; Iskandar Puteri; On-site; MYR 60,000 - 90,000; Full time

Job summary

Kanry Search is seeking a Customer Quality Assurance Engineer to serve as the primary QA contact for assigned customer accounts and to ensure quality requirements are met in manufacturing. You will develop and maintain inspection/control plans for medical components, manage SCAR/RTV processes, and drive containment actions with robust root-cause analysis and CAPA.

The role requires collaboration with cross-functional teams to sustain continuous improvement, maintain quality systems, and ensure

Qualifications

• Bachelor’s degree or diploma in Quality/M manufacturing engineering or related discipline.
• Minimum 3–5 years of experience in Quality Engineering / Customer Quality Engineering, preferably in medical device or similar manufacturing.
• Strong experience handling customer quality issues, complaints, SCAR, RTV and CAPA processes.
• Hands-on with 8D problem solving, RCA, CAPA and continuous improvement.
• Good understanding of quality systems, control plans, inspection plans, PFMEA and manufacturing documentation.
• Experience reviewing Device History Records (DHR), lot records and CoC requirements.
• Knowledge of medical device quality standards and regulatory requirements is a plus.
• Experience with customer audits and quality agreements.

Responsibilities

• Serve as the primary Quality contact for assigned customer accounts.
• Develop and maintain inspection plans and control plans for medical components.
• Manage customer quality issues including SCAR/RTV with containment actions and CAPA.
• Lead 8D problem-solving to identify root causes and sustainable solutions.
• Monitor timely feedback to front-end processes for defects from complaints and inspections.
• Collaborate with Production, Engineering, Supplier Quality and Operations for improvements.
• Maintain quality documentation systems (PMP, PFMEA, work instructions).
• Review changes to processes, materials, tooling for compliance before shipment.
• Ensure Quality Agreement requirements are communicated and maintained at plant level.
• Review DHR, lot records and CoC before issuing Conformance certificates.

Skills

8D problem solving

Root cause analysis

CAPA

Quality systems

PFMEA

DHR/CoC review

Quality audits

Stakeholder management

Documentation control

Education

Bachelor's or Diploma in Quality Engineering

Mechanical/ Manufacturing Engineering

Tools

PFMEA tools

DHR review tools

Document management systems

Job description

Kanry Search is seeking a Customer Quality Assurance Engineer to serve as the primary QA contact for assigned customer accounts and to ensure quality requirements are met in manufacturing. You will develop and maintain inspection/control plans for medical components, manage SCAR/RTV processes, and drive containment actions with robust root-cause analysis and CAPA.

The role requires collaboration with cross-functional teams to sustain continuous improvement, maintain quality systems, and ensure