Supplier Quality Engineer: CAPA & Compliance Leader

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 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.