Post-Market Quality Engineer: Complaint & CAPA Leader

ResMed (UK); Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

ResMed (UK) is seeking a highly motivated QA Engineer, Post Market Quality to support post-market quality activities and ensure the continued safety, performance, and regulatory compliance of products in the field.

This role will work closely with cross-functional teams, including R&D, Regulatory Affairs, Service Operations, Manufacturing, and Customer Quality, to investigate product issues, drive corrective actions, and maintain compliance with applicable quality and regulatory requirements.

Qualifications

• Bachelor's Degree in Engineering, Quality, Life Sciences, Manufacturing, or a related discipline.
• Minimum 5 years of experience in Quality Engineering, Quality Assurance, 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.
• Ability to work effectively in a cross-functional and global environment.

Responsibilities

• Review, assess, and manage customer complaints in line with procedures and regulatory requirements.
• Lead or support investigations into product quality issues, field failures, and customer concerns.
• Perform root cause analysis and ensure timely CAPA implementation.
• Prepare investigation reports and support regulatory reporting when required.
• Analyze data to identify trends and inform corrective actions.
• Support audits and maintain documentation per quality system requirements.

Skills

Analytical skills

Problem-solving

Communication

Stakeholder management

Cross-functional collaboration

Education

Bachelor's Degree in Engineering, Quality, Life Sciences, Manufacturing, or related

Tools

Quality management systems

Data analytics tools

AI/Automation tools (advantage)

Job description

ResMed (UK) is seeking a highly motivated QA Engineer, Post Market Quality to support post-market quality activities and ensure the continued safety, performance, and regulatory compliance of products in the field.

This role will work closely with cross-functional teams, including R&D, Regulatory Affairs, Service Operations, Manufacturing, and Customer Quality, to investigate product issues, drive corrective actions, and maintain compliance with applicable quality and regulatory requirements.