Post-Market QA Engineer (CAPA & Investigations)

ResMed Inc

Johor Bahru

On-site

MYR 150,000 - 210,000

Full time

3 days ago

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Job summary

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

Key responsibilities include complaint handling, post‑market surveillance, trend analysis, and quality system improvements to support

Qualifications

Bachelor's Degree in Engineering, Quality, Life Sciences, Manufacturing, or related discipline.
Minimum 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 activities.
Strong analytical and problem‑solving skills.
Excellent communication and stakeholder management skills.
Ability to work effectively in a cross‑functional and global environment.

Responsibilities

Handle and investigate customer complaints per procedures and regulatory requirements.
Lead or support root cause investigations and CAPA with timely corrective actions.
Analyze post‑market data to identify trends and risks for improvement.
Support quality systems updates and audit readiness across global functions.
Collaborate with R&D, Regulatory, Manufacturing, Service, and Customer Quality teams.