Senior Quality Engineer, Medical Devices & Compliance

Masimo; Pasir Gudang; On-site; MYR 120,000 - 180,000; Full time

Job summary

Masimo, a global medical technology company, seeks a Senior Engineer, Quality to ensure product quality, regulatory compliance, and continuous improvement across R&D and manufacturing. You will liaise between design, production, suppliers, and customers to uphold quality standards and regulatory requirements.

You will support GMP/FDA compliance, manage DHRs and CAPA, and drive improvements through data analysis and cross-functional collaboration.

Qualifications

• 1–3 years in manufacturing, QA, or document control with GMP/FDA 21 CFR Part 820 experience preferred.
• Root Cause Investigation and corrective actions experience
• Proficiency with QA documentation systems and audits

Responsibilities

• Assist Quality Manager on QA and product quality.
• Support new product development and manufacturing via quality tools.
• Ensure compliance with FDA CFR 21 820, ISO 13485, CMDR and other standards.
• Lead/c participate in CAPA, NCR, supplier issues.
• Review DHRs for accuracy and regulatory compliance.
• Apply statistical tools (e.g., Minitab) for quality improvement.
• Collaborate across QA, manufacturing, and engineering to close open items.
• Support internal and external audits and customer feedback processes.

Skills

Quality Assurance

Root Cause Analysis

Project Management

Documentation

Communication Skills

Leadership

Independent Worker

Travel Internationally

Education

Bachelor’s or equivalent in Life Sciences/Engineering/QA

Tools

Microsoft Office

ERP/QMS software

Job description

Masimo, a global medical technology company, seeks a Senior Engineer, Quality to ensure product quality, regulatory compliance, and continuous improvement across R&D and manufacturing. You will liaise between design, production, suppliers, and customers to uphold quality standards and regulatory requirements.

You will support GMP/FDA compliance, manage DHRs and CAPA, and drive improvements through data analysis and cross-functional collaboration.