Post-Market Quality QA Engineer: Investigations & CAPA

ResMed Inc.; Johor Bahru; On-site; MYR 120,000 - 180,000; Full time

Job summary

ResMed Inc. in Johor Bahru, Malaysia is seeking a QA Engineer, Post Market Quality to support post-market activities ensuring safety, performance, and regulatory compliance of devices.

You will investigate product issues, lead CAPAs, perform trend analysis, and collaborate cross-functionally with R&D, Regulatory, Service Ops, and Manufacturing to drive continuous quality improvements. This role focuses on complaint handling, post-market surveillance, audits, and maintaining documentation for

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related discipline.
• Minimum 5 years of experience in Quality Engineering, QA, Post Market Quality, Customer Quality, or similar.
• Experience with complaint handling, investigations, root cause analysis, and CAPA activities.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management skills.

Responsibilities

• Review, assess, 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 CAPAs.
• Prepare investigation reports and support regulatory reporting as required.
• Analyze complaint, service, and field data to identify trends and risks.
• Monitor product performance and drive continuous improvement initiatives.
• Support audits and audit readiness activities; maintain documentation.

Skills

Analytical thinking

Problem solving

Communication

Stakeholder management

Cross-functional collaboration

Education

Bachelor's in Engineering/Quality

Tools

ISO standards knowledge

Quality management systems

Job description

ResMed Inc. in Johor Bahru, Malaysia is seeking a QA Engineer, Post Market Quality to support post-market activities ensuring safety, performance, and regulatory compliance of devices.

You will investigate product issues, lead CAPAs, perform trend analysis, and collaborate cross-functionally with R&D, Regulatory, Service Ops, and Manufacturing to drive continuous quality improvements. This role focuses on complaint handling, post-market surveillance, audits, and maintaining documentation for