Post-Market Quality Engineer: Complaints & CAPA

ResMed; Johor Bahru; Vor Ort; MYR 80.000 - 120.000; Vollzeit

Zusammenfassung

ResMed is seeking a highly motivated QA Engineer, Post Market Quality to support post-market quality activities and ensure the safety, performance, and regulatory compliance of our products. You will work with R&D, Regulatory Affairs, Service Operations, Manufacturing, and Customer Quality to investigate issues, drive corrective actions, and sustain compliance.

The role emphasizes complaint handling, product failure investigations, trend analysis, and post-market surveillance to drive continuous

Qualifikationen

• Bachelor’s Degree in Engineering, Quality, Life Sciences, Manufacturing, or a related discipline.
• 5+ years of experience in Quality Engineering, Quality Assurance, Post Market Quality, Customer Quality, or similar function.
• Experience with complaint handling, investigations, root cause analysis, and CAPA.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management skills.
• Ability to work effectively in a cross-functional and global environment.

Aufgaben

• Manage customer complaints per procedures and regulatory requirements.
• Lead or support investigations into product quality issues and field failures.
• Perform root cause analysis and ensure timely CAPA implementation.
• Prepare investigation reports and support regulatory reporting where required.
• Analyze data to identify trends and emerging risks for continuous improvement.
• Support audits and audit readiness activities; maintain documentation.

Kenntnisse

Quality Engineering

Complaint Handling

Root Cause Analysis

CAPA

Analytical Skills

Cross-functional Collaboration

Ausbildung

Bachelor’s Degree in Engineering/Quality/Life Sciences

Tools

QMS (ISO 13485)

Jobbeschreibung

ResMed is seeking a highly motivated QA Engineer, Post Market Quality to support post-market quality activities and ensure the safety, performance, and regulatory compliance of our products. You will work with R&D, Regulatory Affairs, Service Operations, Manufacturing, and Customer Quality to investigate issues, drive corrective actions, and sustain compliance.

The role emphasizes complaint handling, product failure investigations, trend analysis, and post-market surveillance to drive continuous