Quality Engineer (Medtech)

TL;DR

Quality Engineer (Medtech): Providing technical quality engineering input throughout the product manufacturing process with an accent on compliance, process validation, and inspection activities. Focus on ensuring finished devices meet defined production quality standards, managing non-conformities, and supporting regulatory audits.

Location: Must be based in Pasir Gudang, Malaysia

Company

A global manufacturer specializing in high-quality audio equipment and medical technology solutions.

What you will do

• Provide technical quality engineering input throughout the product manufacturing lifecycle.
• Ensure conformance to internal procedures and international standards including ISO 13485 and FDA CFR 21 820.
• Lead problem-solving activities related to manufacturing, inspection, and supplier issues.
• Conduct IQ/OQ/PQ activities, test method validations, and risk management assessments.
• Develop and manage programs to monitor and predict manufacturing and inspection performance using statistical tools.
• Support quality compliance processes and report effectiveness to management.

Requirements

• B.S. in Science or Engineering required.
• Five to seven years of experience in quality engineering within a device manufacturing environment.
• Direct experience with ISO 13485 and quality system audits.
• Proficiency in root cause investigation, failure analysis, and corrective/preventive actions.
• Strong project management, communication, and documentation skills.
• Ability to travel internationally as required.

Nice to have

• M.S. in Science or Engineering or an MBA.
• Technical knowledge in electronic manufacturing.
• Experience evaluating products against quality standards.

Culture & Benefits

• Opportunity to work in a professional office, laboratory, and manufacturing environment.
• Engagement in high-stakes medical device quality standards.
• Collaborative environment with cross-functional teams.