Post-Market Quality Engineer - Complaints & CAPA Specialist

Medifox DAN GmbH; Johor Bahru; On-site; MYR 120,000 - 180,000; Full time

Job summary

Medifox DAN GmbH seeks a QA Engineer, Post Market Quality to support post-market quality activities ensuring safety, performance, and regulatory compliance of products. The role collaborates with R&D, Regulatory Affairs, Service Operations, Manufacturing, and Customer Quality to investigate issues, drive CAPA, and maintain compliance.

The successful candidate will handle complaint investigations, trend analysis, quality system improvements, and post-market surveillance to support continuous

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum 5 years in quality engineering or post-market quality.
• Experience with complaint handling, investigations, and CAPA.

Responsibilities

• Review and manage customer complaints per procedures and regulatory requirements.
• Lead or support investigations into product quality issues and field failures.
• Perform root cause analysis and implement CAPA.
• Analyze data to identify trends and risks.
• Support audits and maintain quality documentation.

Skills

Analytical skills

Problem solving

Communication

Stakeholder management

Cross-functional work

Education

Bachelor's Degree in Engineering

Job description

Medifox DAN GmbH seeks a QA Engineer, Post Market Quality to support post-market quality activities ensuring safety, performance, and regulatory compliance of products. The role collaborates with R&D, Regulatory Affairs, Service Operations, Manufacturing, and Customer Quality to investigate issues, drive CAPA, and maintain compliance.

The successful candidate will handle complaint investigations, trend analysis, quality system improvements, and post-market surveillance to support continuous