Customer Quality Assurance (Manufacturing)

Details

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.