Quality Assurance Engineer - Product & Supplier

Radiometer; Pasir Gudang; On-site; MYR 50,000 - 70,000; Full time

Benefits offered by this job

Bonus up to 10% of annual base salary

Medical, dental, and optical benefits

Job summary

Masimo, a Danaher operating company, is looking for an Assistant Engineer, Quality to join the Pasir Gudang, Johor site. You will be responsible for product and supplier quality, maintaining the QMS, CAPA, regulatory compliance, and continuous improvement.

This is an on-site role reporting to the Assistant Manager, Quality within the Quality Department. The role requires at least 1 year in manufacturing or product quality and familiarity with ISO 13485 and FDA QSR requirements.

Qualifications

• Familiar with ISO 13485 and FDA QSR requirements.
• Basic knowledge of quality tools and techniques.
• Minimum 1 year of experience in manufacturing or product quality, QMS, or supplier quality.

Responsibilities

• Perform product inspections, quality investigations, validation, KPI monitoring, and CAPA support.
• Maintain QMS documentation, quality records, audits, and regulatory compliance.
• Support supplier quality activities, including qualification, NCR/SCAR follow-up, and supplier improvement.

Skills

Quality

Investigations

CAPA

Education

Bachelor's degree in Engineering/Quality

Tools

QMS familiarity

Job description

Masimo, a Danaher operating company, is looking for an Assistant Engineer, Quality to join the Pasir Gudang, Johor site. You will be responsible for product and supplier quality, maintaining the QMS, CAPA, regulatory compliance, and continuous improvement.

This is an on-site role reporting to the Assistant Manager, Quality within the Quality Department. The role requires at least 1 year in manufacturing or product quality and familiarity with ISO 13485 and FDA QSR requirements.