Customer Quality Assurance (Manufacturing)

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

Customer Quality Assurance (Manufacturing)

Position: Customer Quality Assurance Engineer
Working Hour: Monday to Friday (8:00 a.m. - 5.15 p.m.)
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 3–5 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.