QA Engineer

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

Key responsibilities

Your main responsibilities will include:

1. 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.

2. 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.

3. 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).