Quality Engineer: QA, CAPA & QMS Improvement

Masimo Medical Technologies (Malaysia) Sdn. Bhd.; Pasir Gudang; On-site; MYR 48,000 - 72,000; Full time

Job summary

Masimo Medical Technologies (Malaysia) Sdn. Bhd. is seeking an Assistant Engineer, Quality to ensure end-to-end quality across the product lifecycle.

You will support supplier quality, CAPA activities, and QMS maintenance while collaborating with cross-functional teams to monitor performance and drive improvements. The role involves inspections, data-driven problem solving, and involvement in internal/external audits.

Qualifications

• Minimum 1 year of experience in manufacturing quality, product quality, QMS, and/or supplier quality.
• Familiar with ISO 13485, FDA QSR, and basic quality tools.
• Diploma/Degree in Engineering or related technical field.

Responsibilities

• Perform inspections to ensure product compliance with specifications and quality requirements.
• Monitor yield, defect trends and quality KPIs to identify improvement opportunities.
• Investigate nonconformances, customer complaints and field issues to identify root causes and corrective actions.
• Support validation activities including IQ/OQ/PQ, test method validation, sampling plans, and Gage R&R.
• Work with engineering and production to resolve performance or reliability issues.
• Maintain quality records and release data.
• Assist in QMS maintenance and regulatory compliance (ISO 13485, FDA etc.).
• Assist in document control and maintenance of quality records (SOPs, WI, DHR).
• Participate in audits and management review data collection.

Skills

Analytical skills

Problem-solving

Documentation

Organizational skills

Time management

Communication across teams

Attention to detail

Education

Engineering degree or Diploma

Job description

Masimo Medical Technologies (Malaysia) Sdn. Bhd. is seeking an Assistant Engineer, Quality to ensure end-to-end quality across the product lifecycle.

You will support supplier quality, CAPA activities, and QMS maintenance while collaborating with cross-functional teams to monitor performance and drive improvements. The role involves inspections, data-driven problem solving, and involvement in internal/external audits.