QA Engineer (Post Market Quality)

Location: Johor Bahru, Malaysia

Time Type: Full time

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 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

The successful candidate will:

• 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, apply now!