QA Engineer: Manufacturing Quality & Digital Assurance

ResMed (Malaysia) Sdn Bhd (MY); Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

ResMed (Malaysia) Sdn Bhd (MY) is seeking a quality engineering professional to support manufacturing quality delivery in a regulated environment. The role focuses on applying QA methods to drive quality, availability and value in manufacturing processes, and contributing to product and process introductions with risk-based quality planning.

You will engage in quality planning, validation activities, digital assurance deliverables, and cross-functional collaboration to ensure early quality

Qualifications

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated manufacturing industry.
• Experience with Quality Systems, Manufacturing Quality, risk management and process validation.
• Ability to apply established Quality Engineering methods to support manufacturing quality delivery, investigations, validation and quality by design.
• Independent and proactive learner, able to work under guidance of senior team members while building capability in digital quality, automation, and Quality by Design.

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, digital assurance/CSV/CSA deliverables.
• Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency and standardisation across manufacturing teams.
• Use quality and manufacturing data to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions.
• Contribute to continuous improvement of manufacturing quality systems, processes and engineering practices.
• Provide quality / technical guidance through training, consultation and coaching.
• Partner with Manufacturing Engineering, Operations and other functions to ensure Quality requirements are considered early in process changes.
• Participate in digital quality, automation, advanced manufacturing or transformation pilots, supporting adoption of new quality capabilities.
• Foster a quality culture through education, consultation and day-to-day engagement.
• Ensure risks of non-compliance are identified and mitigated with support from senior team members.
• Ensure compliance to the ResMed QMS and regulatory standards.
• Perform or support internal, external and supplier audits.

Skills

Quality engineering methods

Root cause analysis

Process validation

Risk management

Data-driven decision making

Structured problem solving

AI tools

Quality systems

Digital quality

Cross-functional collaboration

Planning and organisation

Communication skills

Education

Bachelor's degree in Engineering or Science

Tools

AI tools

Job description

ResMed (Malaysia) Sdn Bhd (MY) is seeking a quality engineering professional to support manufacturing quality delivery in a regulated environment. The role focuses on applying QA methods to drive quality, availability and value in manufacturing processes, and contributing to product and process introductions with risk-based quality planning.

You will engage in quality planning, validation activities, digital assurance deliverables, and cross-functional collaboration to ensure early quality