QA Engineer (Post Market Quality)

557 ResMed Malaysia Operations Sdn. Bhd.; Johor Bahru; On-site; MYR 150,000 - 210,000; Full time

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.

Skills

Quality engineering

Quality assurance

Root cause analysis

Data analysis

CAPA

Education

Bachelor's degree in engineering

Job description

About the Role

We are seeking a highly motivated QA Engineer, Post Market Quality to support post‑market quality activities and ensure the continued safety, performance, and 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. The successful candidate will play a key role in complaint handling, product failure investigations, trend analysis, quality system improvements, and post‑market surveillance activities to support continuous improvement and customer satisfaction.

Key Responsibilities

• Complaint Handling & Investigations: Review, assess, and manage customer complaints in accordance with internal procedures and regulatory requirements. Lead or support investigations into product quality issues, field failures, and customer‑reported concerns. Perform root cause analysis and ensure timely implementation of corrective and preventive actions (CAPA). Prepare investigation reports and support regulatory reporting activities where required.
• Post‑Market Surveillance & Trend Analysis: Analyze complaint, service, and field performance data to identify trends, recurring issues, and emerging risks. Recommend improvements and corrective actions based on data‑driven insights. Monitor product performance and collaborate with stakeholders to drive continuous improvement initiatives.
• Quality Systems & Compliance: Support the implementation, maintenance, and continuous improvement of post‑market quality processes and procedures. Ensure compliance with applicable quality standards, regulatory requirements, and internal policies. Participate in internal and external audits and support audit readiness activities. Maintain documentation in accordance with quality system requirements.
• Cross‑Functional Collaboration: Work closely with R&D teams to provide feedback on field performance and quality‑related design improvements. Partner with Regulatory Affairs, Manufacturing, Service, and Customer Support teams to ensure timely resolution of quality issues. Support new product introductions by providing quality and post‑market perspectives during product development activities.
• Continuous Improvement: Identify opportunities to enhance complaint handling, investigation effectiveness, and overall quality system performance. Participate in quality improvement projects and process optimization initiatives. Support the development of service tools, manuals, and post‑market service documentation where applicable.

Qualifications

Required: 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 a 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.

Preferred Experience

Experience in the Medical Device, Healthcare, Pharmaceutical, or other highly regulated industries. Working knowledge of quality management systems and regulatory requirements. Experience conducting data analysis and identifying quality trends. Familiarity with ISO standards, GMP requirements, and post‑market surveillance activities. Experience collaborating with product development and engineering teams. Exposure to AI, automation, or advanced data analytics tools used to support complaint investigations, trend analysis, root cause identification, or continuous quality improvement is considered a strong advantage.

Success in This Role

• Drive timely and effective resolution of customer complaints and product quality issues.
• Ensure compliance with quality system and regulatory requirements.
• Proactively identify trends and recommend improvements to enhance product quality and customer satisfaction.
• Build strong partnerships with cross‑functional teams and contribute to continuous improvement initiatives.
• Serve as a trusted quality partner throughout the product lifecycle.

Joining us is more than saying "yes" to making the world a healthier place.

It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.

If this sounds like the workplace for you.

Resmed (NYSE:RMD, ASX: RMD) creates life‑changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI‑powered digital health solutions, cloud‑connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.