Senior Quality Engineer: Product & Regulatory Excellence

Masimo Medical Technologies (Malaysia) Sdn. Bhd.; Pasir Gudang; On-site; MYR 89,000 - 134,000; Full time

Job summary

Masimo Medical Technologies (Malaysia) Sdn. Bhd. is seeking a Sr Engineer, Quality to uphold product quality, regulatory compliance and continuous improvement across manufacturing and engineering processes.

You will liaise between design, production, suppliers and customers to ensure safety and satisfaction. The role involves leading CAPA initiatives, reviewing DHRs, and applying quality tools to support new product development and manufacturing.

Qualifications

• 1–3 years in manufacturing, QA or document control with GMP/FDA 21 CFR Part 820 exposure.
• Experience with DHR/DMR, quality systems, audits, and documentation control.
• Analytical problem-solving, attention to detail, and team collaboration.

Responsibilities

• Assist Quality Manager on QA and product quality.
• Support new product development and manufacturing via quality tools.
• Ensure conformance to GMP, FDA CFR 21 820, ISO 13485 and CMDR/ec standards.
• Lead problem solving related to design, manufacture and inspection (CAPA, NCR).
• Review DHRs for complete documentation and regulatory compliance.
• Develop and manage programs using statistical tools (Minitab/SQC).
• Document discrepancies and drive corrective actions with teams.
• Support audits and regulatory compliance activities.

Skills

Quality Assurance

GMP Knowledge

FDA Regulations

CAPA & NCR

Root Cause Analysis

Education

Associate’s or Bachelor’s degree in Life Sciences/Engineering/QA

Tools

Microsoft Office

ERP/QMS Software

Job description

Masimo Medical Technologies (Malaysia) Sdn. Bhd. is seeking a Sr Engineer, Quality to uphold product quality, regulatory compliance and continuous improvement across manufacturing and engineering processes.

You will liaise between design, production, suppliers and customers to ensure safety and satisfaction. The role involves leading CAPA initiatives, reviewing DHRs, and applying quality tools to support new product development and manufacturing.