QA Engineer

Ambu; Penang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Ambu A/S is seeking a QA Engineer based in Ambu Sdn Bhd, Malaysia, reporting to the QA (SQOM/IQC) Manager. The role focuses on supplier quality management, CAPA, and regulatory compliance in a dynamic, international environment.

Key responsibilities include leading supplier qualification, monitoring supplier performance against ISO 13485 and FDA 21 CFR Part 820, and driving improvements with key suppliers to ensure reliable materials and quality outcomes.

Responsibilities

• Supplier Quality Management & Issue Resolution.
• Supplier Qualification & Development.
• Supplier Performance Monitoring & Compliance.

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

Your main responsibilities will include:

• 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.

• Supplier Qualification & Development.

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.

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.