Quality Engineer – Medical Devices, ISO 13485

Masimo; Pasir Gudang; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in the medical device industry is looking for a Quality Engineer to ensure product quality through effective engineering practices. The role encompasses quality assurance, process validation, and compliance to international quality standards. Ideal candidates will have extensive experience in quality engineering within a manufacturing environment and a strong educational background in science or engineering.

Qualifications

• 5-7 years in quality engineering in a device manufacturing environment.
• Direct experience with ISO 13485 and quality system audits.
• Strong communication, documentation, and leadership skills.

Responsibilities

• Assist Quality Manager on quality assurance and product quality.
• Leads problem-solving activities related to manufacture and inspections.
• Develops programs to monitor and regulate manufacturing activities.

Skills

Root Cause Investigation

Problem Solving

Project Management

Communication

Leadership

Education

B.S. in Science or Engineering

M.S. in Science or Engineering

MBA

Tools

Minitab

SQC Pack

Job description

A leading company in the medical device industry is looking for a Quality Engineer to ensure product quality through effective engineering practices. The role encompasses quality assurance, process validation, and compliance to international quality standards. Ideal candidates will have extensive experience in quality engineering within a manufacturing environment and a strong educational background in science or engineering.