QA Engineer

Ambu; Penang; On-site; MYR 60,000 - 90,000; Full time

Job summary

Ambu A/S in Malaysia is seeking a QA Engineer to join Ambu Sdn Bhd, focusing on supplier quality management and ensuring CAPA processes align with ISO 13485 and FDA requirements.

You will lead supplier qualification, development, audits and ongoing performance monitoring, driving data analysis and corrective actions to improve supply chain quality.

Qualifications

• Experience in supplier quality management and CAPA processes.
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 is advantageous.
• Ability to lead supplier audits and improvements.

Responsibilities

• Manage supplier quality performance and drive CAPA actions.
• Lead supplier qualification, approval, and auditing activities.
• Monitor supplier metrics and ensure QMS/regulatory compliance.

Skills

Supplier Quality Management

CAPA

Auditing

Data analysis

Job description

Ambu A/S is currently looking for a QA Engineer to be based in Ambu Sdn Bhd.

Key Responsibilities

Your main responsibilities will include:

• Supplier Quality Management & Issue Resolution (40%) Manage overall supplier quality performance, investigate supplier-related nonconformances, drive root cause analysis, and ensure effective corrective and preventive actions (CAPA) to prevent recurrence.
• Supplier Qualification & Development (35%) Lead supplier qualification, approval, and auditing processes. Work closely with key suppliers to improve capability, quality performance, and reliability of supplied materials.
• Supplier Performance Monitoring & Compliance (25%) Monitor supplier quality metrics, analyze data trends, and ensure supplier management processes comply with the company Quality Management System and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).