Senior Customer Quality Engineer - Medical Devices

Kanry Search; Iskandar Puteri; On-site; MYR 120,000 - 180,000; Full time

Job summary

Kanry Search is seeking a Customer Quality Manager (Medical Devices) to be based in Iskandar Puteri, Johor. You will serve as the primary quality contact for key customer accounts and ensure performance targets are met.

You will develop inspection and control plans, manage SCAR/RTV actions with CAPA, and drive 8D problem solving across cross-functional teams to prevent recurrence. The role requires 7+ years in quality engineering within medical devices or related fields.

Qualifications

• Bachelor’s Degree / Diploma in Quality Engineering, Mechanical Engineering, Manufacturing Engineering or related disciplines.
• Minimum 7 years of experience in Quality Engineering / Customer Quality Engineering, preferably in medical device, semiconductor, electronics or precision manufacturing industries.
• Strong experience in handling customer quality issues, complaints, SCAR, RTV and corrective action processes.
• Hands-on experience with 8D problem-solving, RCA, CAPA and continuous improvement activities.
• Good understanding of quality systems, control plans, inspection plans, PFMEA, PMP, Work Instructions and manufacturing documentation.
• Experience in reviewing and maintaining DHR, lot records and CoC requirements.
• Familiar with medical device quality standards and regulatory requirements; experience with customer quality audits and agreements is a plus.

Responsibilities

• Serve as the primary Quality contact for assigned customer accounts, ensuring customer quality requirements and performance targets are achieved.
• Develop and maintain inspection plans and control plans for medical components per customer specs.
• Manage customer quality issues, including SCAR and RTV responses, driving containment actions, RCA, CAPA and verification of effectiveness.
• Lead structured problem-solving using 8D methodology to identify root causes and implement sustainable solutions.
• Monitor and ensure timely feedback and corrective actions for defects identified through customer complaints and inspections.
• Collaborate with cross-functional teams (Production, Engineering, Supplier Quality, Process and Operations) to drive continuous improvement and prevent recurrence.
• Maintain and update quality documentation systems (PMP, PFMEA, Work Instructions and related docs).
• Manage customer change notifications by reviewing process, material, tooling and supplier changes before shipment.
• Ensure Quality Agreement requirements are communicated and maintained at plant level.
• Review DHR, lot records and CoC to ensure product compliance before issuing CoC to customers.

Skills

Quality Engineering

Customer Quality

8D Problem Solving

Root Cause Analysis

CAPA

Continuous Improvement

Stakeholder Management

Documentation & Compliance

Process Improvement

Education

Bachelor’s or Diploma in Quality Engineering / Mechanical Engineering / Manufacturing Engineering

Tools

PFMEA

PMP

DHR/CoC documentation

Job description

Kanry Search is seeking a Customer Quality Manager (Medical Devices) to be based in Iskandar Puteri, Johor. You will serve as the primary quality contact for key customer accounts and ensure performance targets are met.

You will develop inspection and control plans, manage SCAR/RTV actions with CAPA, and drive 8D problem solving across cross-functional teams to prevent recurrence. The role requires 7+ years in quality engineering within medical devices or related fields.