Quality Engineer, Medical Devices — Onsite Impact

Masimo; Pasir Gudang; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Phone allowance

Medical card

Dental allowance

Optical allowance

Job summary

Masimo, a Danaher operating company, seeks a Quality Engineer to assure conformance of processes and systems during manufacture and QC. The role involves leading problem solving, IQ/OQ/PQ activities and risk management to maintain product quality.

On-site in Malaysia, you will support NCR data generation and inspections, requiring a B.S. in Science or Engineering and relevant ISO 13485 experience. MBA or M.S. is a plus for advancement.

Qualifications

• B.S. in Science or Engineering required.
• M.S. in Science or Engineering or MBA preferred.
• Experience in quality engineering in a device manufacturing environment.
• Direct experience with ISO 13485 is essential.

Responsibilities

• Assure conformance of systems and processes during manufacture and quality control to applicable standards.
• Lead and participate in problem solving related to manufacturing and inspection.
• Participate in IQ/OQ/PQ activities and risk management to ensure product quality.
• Support quality compliance with data generation for NCR and inspections.

Skills

Quality engineering

Manufacturing experience

Regulatory compliance

Problem solving

Gage R&R

Education

B.S. in Science or Engineering

M.S. in Science or Engineering or MBA

Tools

IQ/OQ/PQ

Gage R&R

Job description

Masimo, a Danaher operating company, seeks a Quality Engineer to assure conformance of processes and systems during manufacture and QC. The role involves leading problem solving, IQ/OQ/PQ activities and risk management to maintain product quality.

On-site in Malaysia, you will support NCR data generation and inspections, requiring a B.S. in Science or Engineering and relevant ISO 13485 experience. MBA or M.S. is a plus for advancement.