QA Engineer - Manufacturing (Fixed Term)

About the role

ResMed is hiring a QA Engineer for its manufacturing function in Singapore on a fixed-term basis. The role supports manufacturing quality by applying quality engineering methods, helping introduce new products, processes and technologies, and ensuring compliance with the ResMed QMS and regulatory standards.

Key responsibilities

• Support manufacturing to achieve quality, availability and value objectives through quality engineering methods.
• Take part in introducing new products, processes, technologies and manufacturing capabilities, using Quality by Design, risk-based quality planning and quality controls through XFT deliverables and phase transitions.
• Support manufacturing readiness, including quality planning, risk assessments, validation activities, digital assurance/CSV/CSA deliverables, control strategy execution and launch/post-launch learning.
• Apply manufacturing QA standards, methods, playbooks and tools to standardise approaches across manufacturing teams.
• Use quality and manufacturing data (NCP/CAPA, validation outputs, audit findings, process performance) to spot trends, support investigations and recommend preventive actions.
• Contribute to continuous improvement of quality systems and processes, and provide quality and technical guidance through training, consultation and coaching.
• Partner with Manufacturing Engineering, Operations and other functions so quality requirements are considered early in process, equipment, technology, automation, MES and digital manufacturing changes.
• Take part in digital quality, automation, advanced manufacturing or transformation pilots where required.
• Identify, assess and mitigate risks of non-compliance and business risks, and ensure compliance with the ResMed QMS and applicable regulatory standards.
• Perform or support internal, external and supplier audits as required.

Required profile

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated volume manufacturing industry.
• Experience or exposure in Quality Systems, Manufacturing Quality, risk management, process validation and structured root cause/problem-solving methodologies.
• Ability to apply quality engineering methods to manufacturing quality delivery, investigations, validation and quality planning and improvement.
• Independent and proactive learner who can work under the guidance of senior team members.
• Good planning and organisational skills, strong communication and collaboration skills.

Preferred

• Quality and/or regulatory experience in the medical device industry.
• Experience in Quality Systems, Manufacturing Quality, process validation and risk management.
• Capability in using AI tools or data-driven technologies for efficiency and quality insights.
• Exposure to MES, digital quality, CSV/CSA, automation, advanced analytics, Quality by Design or advanced quality planning.
• Interest in advancing toward senior technical Quality Engineering contributions.