Job Description

Working Days & Time: * Monday – Thursday | 8am – 6pm * Friday | 8am – 5pm Working Location: * Kulai, Johor Job Requirements: • Bachelor's Degree or Diploma in Engineering, Quality Management or a related field. • Experience 2years in a manufacturing environment is preferred. • Knowledge of ISO 9001-2015, ISO 14001-2015, ISO 13485-2016 Quality Management System. • Familiarity with quality tools such as 8D, CAPA, FMEA, SPC, MSA and Root Cause Analysis. • Experience in conducting internal audits and handling customer complaints. • Proficient in Microsoft Office, especially Excel and report preparation. • Good analytical, problem-solving and communication skills. • Able to work independently and collaborate with cross-functional teams. • Detail-oriented, systematic and committed to continuous improvement. Job Responsibilities / Job Duties 1. Develop, implement and maintain the Quality Management System (QMS) in accordance with ISO 9001-2015, ISO 14001-2015, ISO 13485-2016 and applicable customer requirements. 2. Ensure all manufacturing processes comply with established quality standards, specifications and procedures. 3. Monitor and analyse product quality performance, production defects and customer complaints. 4. Conduct internal audits and coordinate external audits, customer audits and certification audits. 5. Investigate non-conformities and implement corrective and preventive actions (CAPA). 6. Perform root cause analysis using appropriate quality tools, such as 5 Why Analysis, Fishbone Diagram and 8D Reports. 7. Monitor and review inspection results, testing records and quality reports to ensure product conformity. 8. Work closely with Production, Engineering, QC and other departments to resolve quality issues. 9. Establish and maintain quality documentation, including procedures, work instructions, inspection standards and quality records. 10. Coordinate with suppliers regarding incoming material quality issues and corrective actions, where applicable. 11. Analyse quality data and prepare reports on defect rates, rejection rates, customer complaints and other quality performance indicators. 12. Lead continuous improvement activities to reduce defects, scrap, rework and production costs. 13. Ensure corrective actions are implemented effectively and verify their effectiveness. 14. Provide quality awareness training to employees and production personnel. 15. Support new product introduction, process changes and customer quality requirements, where applicable. 16. Ensure compliance with relevant company procedures, safety requirements and applicable regulatory standards. 17. Perform other quality-related duties as assigned by the superior.