Senior Quality Engineer (Medical Devices)

Location: On-site in Pasir Gudang, Johor, Malaysia

Company

Masimo is a hirify.global operating company developing and manufacturing medical monitoring technologies, sensors, patient monitors, and automation and connectivity solutions.

What you will do

• Support quality assurance, product quality, new product development, and manufacturing activities.
• Ensure compliance with internal procedures, FDA CFR 21 Part 820, ISO 13485, Canadian Medical Device Requirements, MDD 93/42/EEC, and other applicable international standards.
• Lead and participate in problem-solving activities covering design, manufacturing, inspection, testing, CAPA, NCRs, and supplier-related issues.
• Analyze significant quality issues and provide resolution plans and recommendations to management.
• Review Device History Records for completeness, accuracy, product conformity, and regulatory compliance.
• Develop and manage monitoring programs using statistical tools such as Minitab and SQC Pack.

Requirements

• Associate’s or bachelor’s degree in life sciences, engineering, quality assurance, or a related field.
• Experience in manufacturing, quality assurance, or document control.
• Knowledge of root cause investigation, failure analysis, root cause verification, and corrective and preventive actions.
• Working knowledge of Device History Records, Device Master Records, and quality system documentation.
• Strong attention to detail and ability to identify inconsistencies or missing documentation.
• Direct experience with quality system audits; GMP and FDA 21 CFR Part 820 experience is highly preferred.

Culture & Benefits

• Continuous improvement through the hirify.global Business System.
• Health care programs and paid time off.
• Annual base salary incentive opportunity of up to 10%, subject to eligibility and performance conditions.