- Pasir Gudang Pasir Gudang Johor Malaysia 81700

Working Location
Job Description
Requirements
Bachelor's Degree in Engineering, Science, or a related field
Minimum 5 years of experience in Manufacturing Engineering, Quality Engineering, or a related function
Strong experience in root cause analysis, process improvement, and quality problem-solving methodologies
Excellent communication and stakeholder management skills
Ability to work cross-functionally with suppliers, contract manufacturers, engineering, quality, and supply chain teams
Willingness to travel up to 20%, including international travel
Able to communicate in English & Mandarin
Preferred Skills
Experience in Medical Device or Biotechnology Manufacturing
Familiarity with ISO 13485 and FDA 21 CFR Part 820 requirements
Knowledge of manufacturing processes such as injection moulding, assembly, sterilization, and automated production systems
Experience supporting new production line ramp-up and process validation activities
Responsibilities
Lead root cause investigations for quality and production issues using structured problem-solving tools such as 5 Whys, Fishbone Analysis, and FMEA
Develop and implement corrective and preventive actions to improve product quality and manufacturing performance
Conduct incoming inspections to ensure components and assemblies meet required specifications
Drive continuous improvement initiatives to reduce defects, improve yield, and enhance operational efficiency
Support new product introductions, pilot runs, scale-up activities, and production transfers
Collaborate with contract manufacturers, suppliers, engineering, quality, and production teams to resolve manufacturing challenges
Create and maintain BOMs, SOPs, work instructions, qualification plans, and other manufacturing documentation
Analyze manufacturing yield and OEE performance while identifying opportunities for optimization
Review supplier process controls, engineering changes, and qualification requirements for automated testing equipment
Benefits
Skills
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