全职 Medical Devices : Manufacturing Engineer 工作, 薪水 up to MYR 6,000, PERSOL Workforce Solutions Malaysia Johor 公司招聘中 - Ricebowl

• 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

• 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

• EPF
• SOCSO
• Allowance Provided
• Annual Leave
• Medical and Hospitalisation Leave
• EIS