QA Engineer

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

Job summary

Ambu Sdn Bhd is seeking a QA Engineer to ensure supplier quality and regulatory compliance. You will report to the QA Manager and contribute to CAPA activities, supplier qualification, and audits within a global, interdisciplinary team.

The role focuses on improving quality performance of supplied materials, monitoring metrics, and maintaining alignment with ISO 13485 and FDA requirements in an international environment.

Responsibilities

• Manage supplier quality performance and investigate nonconformances to drive CAPA for recurrence prevention.
• Lead supplier qualification, approval and auditing processes; monitor metrics and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.

Job description

Ambu A/S is currently looking for a QA Engineer to be based in Ambu Sdn Bhd. This role will be reporting to the QA(SQOM/IQC) Manager.

Key responsibilities

• Supplier Quality Management & Issue Resolution. Manage overall supplier quality performance, investigate supplier-related nonconformances, drive root cause analysis, and ensure effective corrective and preventive actions (CAPA) to prevent recurrence. Lead supplier qualification, approval, and auditing processes. Work closely with key suppliers to improve capability, quality performance, and reliability of supplied materials. 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).

Ambu - a visionary and international workplace where your efforts matter Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.