Quality Engineer, Medical Devices & ISO 13485

Radiometer; Pasir Gudang; On-site; MYR 90,000 - 150,000; Full time

Job summary

Masimo, a Danaher operating company, seeks an Engineer, Quality to support quality engineering across the product manufacturing process in Pasir Gudang, Johor. The role reports to the Assistant Manager, Quality and is an on-site position within the Quality Department.

You will drive conformance to internal procedures and international standards such as FDA CFR 21 820, ISO 13485, and CMDR, while leading NCR, supplier issues, and IQ/OQ/PQ activities to ensure robust product quality.

Qualifications

• Bachelor or higher in science or engineering required.
• MS or MBA preferred for advanced roles.
• Experience in quality engineering in device manufacturing.
• Experience evaluating products to quality standards.
• Direct experience with ISO 13485.

Responsibilities

• Provide technical input for quality engineering throughout manufacturing.
• Lead problem solving for manufacture, inspection and test issues.
• Participate in IQ/OQ/PQ activities and risk management.
• Support quality compliance data generation for NCR and inspections.

Skills

Quality engineering

Regulatory compliance

Problem solving

Equipment testing

Education

B.S. in Science or Engineering

M.S. in Science or Engineering or MBA

Tools

Gage R&R

IQ/OQ/PQ

Job description

Masimo, a Danaher operating company, seeks an Engineer, Quality to support quality engineering across the product manufacturing process in Pasir Gudang, Johor. The role reports to the Assistant Manager, Quality and is an on-site position within the Quality Department.

You will drive conformance to internal procedures and international standards such as FDA CFR 21 820, ISO 13485, and CMDR, while leading NCR, supplier issues, and IQ/OQ/PQ activities to ensure robust product quality.