QA Engineer

Ambu A/S; Malaysia; Hybrid; MYR 60,000 - 96,000; Full time

Job summary

Ambu A/S is seeking a QA Engineer based in Malaysia to oversee supplier quality management, CAPA, and supplier development in our Ambu Sdn Bhd operations. You will drive supplier qualification, auditing, and ongoing performance monitoring to ensure high quality and reliability of materials.

The role requires collaboration with global suppliers and a strong focus on compliance with ISO 13485 and FDA 21 CFR Part 820 throughout the supplier network.

Qualifications

• Experience in supplier quality management and CAPA activities.
• Familiarity with ISO 13485 or FDA 21 CFR Part 820 is a plus.
• Proven ability to lead supplier qualification and audit processes.

Responsibilities

• Manage supplier quality performance, investigate nonconformances, drive root cause analysis, and implement CAPA to prevent recurrence.
• Lead supplier qualification, approval, and auditing, collaborating with key suppliers to improve capability and quality.
• Monitor supplier quality metrics and ensure compliance with the QMS and regulatory requirements.

Skills

Supplier Quality Management

CAPA

Root Cause Analysis

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:

1. 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.

2. 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.

3. 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).

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.