Supplier Quality Engineer: CAPA, Audits & Compliance

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 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.