Assistant Quality Engineer – QA & Compliance

Masimo Corporation; Kuala Lumpur; On-site; MYR 56,000 - 78,000; Full time

Job summary

Masimo Corporation in Kuala Lumpur is hiring an Assistant Engineer, Quality to safeguard end-to-end quality across the product lifecycle, including QA, supplier quality performance, and QMS maintenance.

You will work with cross-functional teams to monitor performance, manage nonconformities, support CAPA activities, and ensure regulatory compliance, driving continuous improvements. Diploma/degree in engineering required.

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.

Responsibilities

• Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements.
• Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
• Conduct investigations on product nonconformance, customer complaints, returned products, 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 closely with engineering and production teams to resolve product performance or reliability issues.
• Maintain product quality records, including inspection reports, validation documents, and product release data.
• Support implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, FDA 21 CFR 820, CMDR, MDD 93/42 EEC, and internal procedures.
• Assist in document control and maintenance of quality records including SOPs, WI, DHR and etc.
• Participate in internal and external audits, including preparation of documentation, execution support, and management of audit findings.
• Support the management review process by collecting NCR, CAPA, audit, complaint, and quality performance data.
• Assist in supplier qualification activities, including documentation review and raising First Article Inspection Reports (FAIR) requests as required.
• Monitor supplier performance, incoming inspection results, and supplier-related nonconformity trends.
• Participate in supplier NCR and SCAR investigations; help follow up on corrective action implementation and effectiveness.
• Work with suppliers to improve component quality and reduce recurring quality issues.
• Any reasonable task assigned by superior, as applicable

Skills

Quality Assurance

CAPA

Documentation

Analytical Skills

Education

Diploma/Degree in Engineering or related technical field

Job description

Masimo Corporation in Kuala Lumpur is hiring an Assistant Engineer, Quality to safeguard end-to-end quality across the product lifecycle, including QA, supplier quality performance, and QMS maintenance.

You will work with cross-functional teams to monitor performance, manage nonconformities, support CAPA activities, and ensure regulatory compliance, driving continuous improvements. Diploma/degree in engineering required.