Quality Engineer – Digital QA & Manufacturing Excellence

ResMed (Malaysia) Sdn Bhd; Johor Bahru; On-site; MYR 90,000 - 130,000; Full time

Job summary

ResMed (Malaysia) Sdn Bhd is seeking a Quality Assurance Engineer to support manufacturing quality, risk management and product introductions. The role focuses on quality planning, validation and data-driven investigations to ensure compliant, efficient production processes.

The successful candidate will apply Quality by Design, maintain QMS compliance, collaborate with cross-functional teams and contribute to continuous improvement initiatives across manufacturing.

Qualifications

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated volume manufacturing industry.
• Experience in Quality Systems, Manufacturing Quality, risk management, process validation and structured root cause/problem-solving methodologies.
• Ability to apply established Quality Engineering methods to support manufacturing quality delivery, investigations, validation, digital assurance/CSV/CSA deliverables where applicable, quality planning and improvement activities.
• Independent and proactive learner, able to work under guidance of senior team members while building capability in digital quality, automation, advanced manufacturing, digital assurance and Quality by Design.
• Ability to use quality data and manufacturing information to identify trends, support decisions and recommend improvements.
• Good planning and organisational skills, with the ability to take initiative and ownership of assigned deliverables.
• Strong communication and collaboration skills, with the ability to build positive working relationships with manufacturing, engineering and quality partners.

Responsibilities

• Support Manufacturing to achieve Quality, Availability and Value objectives by applying established Quality Engineering methods and contributing to reliable manufacturing quality performance.
• Participate in and support new product, process, technology and manufacturing capability introduction, applying Quality by Design and risk-based quality planning.
• Support manufacturing readiness activities, including quality planning, risk assessments, validation activities and digital assurance deliverables.
• Apply established Manufacturing QA standards, methods and tools to support consistency and adoption across manufacturing teams.
• Use quality and manufacturing data to identify trends, support investigations, recommend preventive actions and contribute to future Quality Engineering solutions.
• Contribute to continuous improvement of manufacturing quality systems, processes and engineering practices.

Skills

Quality Systems

Manufacturing Quality

Risk Management

Process Validation

Root Cause Analysis

Structured Problem Solving

Data-driven Decision Making

Digital Quality

Quality by Design

Automation

Cross-functional Collaboration

Education

Bachelor's degree in Engineering or Science

Tools

Quality Management System (QMS)

CSV/CSA

MES

Job description

ResMed (Malaysia) Sdn Bhd is seeking a Quality Assurance Engineer to support manufacturing quality, risk management and product introductions. The role focuses on quality planning, validation and data-driven investigations to ensure compliant, efficient production processes.

The successful candidate will apply Quality by Design, maintain QMS compliance, collaborate with cross-functional teams and contribute to continuous improvement initiatives across manufacturing.