Senior Quality Engineer - Life Sciences & GMP

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

Benefits offered by this job

Bonus up to 10%

Job summary

Masimo, part of the Danaher family, is seeking a Sr Engineer, Quality to ensure product quality, regulatory compliance, and continuous improvement in Pasir Gudang, Johor. This on-site role acts as a liaison among design, production, suppliers, and customers to uphold stringent quality standards.

The role involves QA activities across product development through manufacturing, CAPA/ NCR handling, and DHR/DMR documentation, with exposure to GMP and FDA 21 CFR Part 820.

Qualifications

• Associate’s or Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field.
• Experience with GMP and FDA 21 CFR Part 820 compliance is highly preferred.
• Strong root-cause investigation and corrective/preventive action capability.
• Working knowledge of DHR/DMR and quality system documentation.

Responsibilities

• Ensure product quality, regulatory compliance, and continuous improvement across manufacturing and engineering processes.
• Lead problem solving related to design, manufacture and inspection and test including CAPA and NCR.
• Coordinate with design, production, suppliers and customers to uphold quality standards.
• Review Device History Records and ensure proper documentation meets specs and regulatory requirements.
• Apply statistical tools (e.g., Minitab) to monitor and improve processes.

Skills

Quality assurance

GMP compliance

Root cause analysis

CAPA

Education

Bachelor's degree in Life Sciences or related field

Tools

Minitab

Job description

Masimo, part of the Danaher family, is seeking a Sr Engineer, Quality to ensure product quality, regulatory compliance, and continuous improvement in Pasir Gudang, Johor. This on-site role acts as a liaison among design, production, suppliers, and customers to uphold stringent quality standards.

The role involves QA activities across product development through manufacturing, CAPA/ NCR handling, and DHR/DMR documentation, with exposure to GMP and FDA 21 CFR Part 820.