Customer Quality Manager (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

Customer Quality Manager (Medical Devices)

Working Hour: Monday to Friday
Location: Iskandar Puteri, Johor

Job Description

Serve as the primary Quality contact for assigned customer accounts, ensuring customer quality requirements and performance targets are consistently achieved.

Develop and maintain inspection plans and control plans for medical components in accordance with customer specifications and quality requirements.

Manage customer quality issues, including SCAR and RTV responses, by driving containment actions, root cause analysis, corrective and preventive actions (CAPA), and verification of effectiveness.

Lead structured problem-solving activities using 8D methodology to identify root causes and implement sustainable solutions.

Monitor and ensure timely feedback and corrective actions are provided to front-end processes for defects identified through customer complaints and internal inspections.

Collaborate with cross-functional teams (Production, Engineering, Supplier Quality, Process and Operations) to drive continuous improvement initiatives and prevent recurrence of quality issues.

Maintain and update quality documentation systems, including Process Management Plans (PMP), PFMEA, Work Instructions and other related quality documents.

Manage customer change notifications by reviewing process, material, tooling and supplier changes to ensure compliance with customer requirements before product shipment.

Ensure Quality Agreement requirements are effectively communicated, implemented and maintained at the plant level.

Review lot records, Device History Records (DHR) and quality documentation to ensure product compliance before issuing Certificates of Conformance (CoC) to customers.

Job Requirements

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 within 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 methodology, root cause analysis (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 Device History Records (DHR), lot records and Certificate of Conformance (CoC) requirements.

Familiar with medical device quality standards and regulatory requirements will be an added advantage.

Experience working with customers on quality audits, quality agreements and customer-specific requirements.

Strong knowledge of manufacturing processes, defect analysis and process improvement methodologies.

Good communication and stakeholder management skills with the ability to work closely with customers and cross-functional teams.

Detail-oriented, analytical and able to manage multiple quality issues in a fast-paced manufacturing environment.

Preferred Skills / Certifications

Knowledge of ISO 13485 Quality Management System.

Experience with medical device manufacturing requirements.

Certified 8D Problem Solving / Lean Six Sigma / Quality-related certifications would be an advantage.