Quality Assurance Assistant Engineer – QMS & Suppliers

Masimo; Pasir Gudang; On-site; MYR 60,000 - 80,000; Full time

Job summary

Masimo in Pasir Gudang, Malaysia, seeks an Assistant Engineer, Quality to oversee end-to-end quality across the product lifecycle, including QA, supplier performance, and QMS maintenance.

You will collaborate with engineering and production to resolve quality issues, support CAPA, audits, and documentation, and ensure compliance with ISO 13485 and FDA QSR. Some domestic travel may be 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 incoming, in-process, and final inspections to ensure product quality.
• Monitor quality KPIs and manage nonconformities and CAPA activities.
• Support QMS documentation, audits, and supplier qualification.
• Assist in supplier NCR/SCAR investigations and corrective actions.
• Collaborate with engineering and production to resolve quality issues.
• Assist in document control and quality records maintenance.

Skills

Manufacturing quality

QMS

Supplier quality

ISO 13485 familiarity

Education

Engineering degree

Job description

Masimo in Pasir Gudang, Malaysia, seeks an Assistant Engineer, Quality to oversee end-to-end quality across the product lifecycle, including QA, supplier performance, and QMS maintenance.

You will collaborate with engineering and production to resolve quality issues, support CAPA, audits, and documentation, and ensure compliance with ISO 13485 and FDA QSR. Some domestic travel may be required.