Quality Engineer

Job Responsibilities

• Develop and maintain Quality Control Plans, Inspection Work Instructions and quality standards, define critical quality control points, and monitor their effective implementation.​

  • Establish product measurement and testing requirements, implement appropriate SPC (Statistical Process Control) during production, and perform quality data analysis and monitoring.​

  • Review product manufacturing environment requirements, establish product appearance/visual standards, and develop appropriate sampling plans covering incoming inspection, in-process inspection and finished product inspection.​

  • Act as the quality contact for customers during new product introduction (NPI), coordinate customer quality requirements, conduct quality risk assessments, and ensure quality requirements are properly implemented throughout project introduction.​

  • Monitor product quality during new product trial runs, identify potential quality risks and provide recommendations for improvement.​

  • Lead quality improvement activities during NPI and mass production, investigate process quality issues, follow up on corrective actions, and drive continuous quality improvement.​

  • Work closely with Engineering teams on product, process, equipment and fixture validation activities, and prepare or support relevant validation and quality reports.​

  • Lead or support the investigation and resolution of customer complaints and quality issues, including root cause analysis, corrective and preventive actions, and effectiveness verification.​

  • Communicate customer quality requirements and product quality information internally, and provide training to inspectors and relevant production personnel on quality standards and inspection requirements.​

  • Perform other quality-related duties assigned by the Quality Manager.

Job Requirements

• Bachelor's Degree or above in Engineering, Quality Management or other relevant disciplines.​

  • Familiar with ISO 13485 Quality Management System; experience in the medical device manufacturing industry is preferred.​

  • Good understanding of manufacturing processes and material characteristics, with the ability to apply quality tools for problem-solving and continuous improvement.​

  • Familiar with quality tools and methodologies such as SPC, 8D, FMEA, MSA, CAPA and Root Cause Analysis.​

  • Strong data analysis, problem-solving and quality risk assessment capabilities.​

  • Good communication, coordination and cross-functional collaboration skills.​

  • Responsible, detail-oriented and able to work independently as well as effectively within a team.​

  • Proficient in Mandarin, Bahasa Malaysia and English, both written and spoken.​

  • Willing to work in Ulu Tiram, Johor.

"We are looking for Mandarin-speaking candidates who will be serving Mandarin-speaking customers."

What We Offer

• EPF, SOCSO and EIS contributions.
• Overtime payment in accordance with applicable requirements.
• Annual Leave and Medical Leave.
• Public Holidays.
• Performance-related rewards/benefits subject to company policy.
• On-the-job training and development opportunities.
• Stable working environment and career development opportunities.

Work Location: Ulu Tiram, Johor