QA Engineer - Manufacturing (Fixed Term)

ResMed; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

ResMed in Singapore seeks a Quality Engineer to support manufacturing quality objectives through established QbD methods, risk-based planning and robust validations. You will help introduce new products and processes, ensure readiness, and drive improvements across QA standards and data-driven investigations.

The role emphasizes collaboration with Manufacturing Engineering, Operations and cross-functional teams, applying Quality by Design and digital assurance practices to reduce defects and

Qualifications

• Bachelor’s degree in Engineering or Science required.
• 3+ years’ experience in a regulated volume manufacturing industry is required.
• Experience with Quality Systems, Manufacturing Quality, risk management and process validation is preferred.
• Ability to apply Quality Engineering methods to support manufacturing quality delivery and investigations.
• Independent learner who can work under guidance while building capability in digital quality and CSA/CSV.

Responsibilities

• Support Manufacturing to achieve Quality, Availability and Value objectives using established Quality Engineering methods.
• Participate in the introduction of new products, processes, technology and manufacturing capability with QbD and risk-based quality planning.
• Support manufacturing readiness activities including quality planning, validation and control strategy execution.
• Apply Manufacturing QA standards to promote consistency and standardisation across manufacturing teams.
• Use quality data and learnings to identify trends, support investigations, and drive preventive actions and improvements.
• Contribute to continuous improvement of manufacturing quality systems and engineering practices.
• Provide quality guidance through training, consultation and coaching in problem solving, risk management and data-driven decision making.
• Partner with Manufacturing Engineering, Operations and other functions to consider Quality early in process and automation changes.
• Participate in digital quality, automation, advanced manufacturing or transformation pilots and engage CSV/CSA expertise when needed.
• Foster a quality culture through education and day-to-day engagement with manufacturing partners.
• Ensure compliance to the ResMed QMS and applicable regulatory standards.
• Perform or support audits as required.

Skills

Quality Engineering

Risk Management

Process Validation

Root Cause Analysis

Digital Assurance

Quality by Design

Data-driven Decision Making

Education

Bachelor’s degree in Engineering or Science

Job description

Let’s talk about 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, risk-based quality planning and appropriate quality controls through XFT deliverables and phase transitions.
• Support manufacturing readiness activities, including quality planning, risk assessments, validation activities, digital assurance/CSV/CSA deliverables where applicable, control strategy execution and launch/post-launch learning.
• Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardisation and adoption of proven approaches across manufacturing teams.
• Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, 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, supporting improved Right First Time performance and reduction of repeat or systemic quality issues.
• Provide quality / technical guidance through training, consultation and coaching, building capability in structured problem solving, risk management, process validation, digital assurance awareness and data-driven decision making.
• Partner with Manufacturing Engineering, Operations and other functions to ensure Quality requirements are considered early in process, equipment, technology, automation, MES and digital manufacturing changes.
• Participate in digital quality, automation, advanced manufacturing or transformation pilots where required, supporting development, testing and operational adoption of new quality capabilities and engaging specialist CSV/CSA expertise where applicable.
• Foster a quality culture through education, consultation and day-to-day engagement with manufacturing and cross-functional partners.
• Ensure risks of non-compliance and related business risks are identified, assessed and mitigated with support from senior team members where required.
• Ensure compliance to the ResMed QMS and applicable regulatory standards.
• Perform or support internal, external and supplier audits as required.

Let’s talk about Qualifications and Experience

Required

• 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 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.

Preferred

• Experience in Quality and/or Regulatory positions in the medical device industry.
• Experience in Quality Systems, Manufacturing Quality, process validation and risk management methodologies.
• Demonstrated capability in using AI tools or data-driven technologies for efficiency improvement, quality insights and decision support.
• Exposure to MES/digital quality, CSV/Computer Software Assurance (CSA), automation, advanced analytics, Quality by Design or advanced quality planning.
• Exposure to manufacturing readiness, new product introduction, process technology changes, equipment changes, validation activities or software-enabled manufacturing systems in a regulated environment.
• Interest in developing toward senior technical Quality Engineering contribution across manufacturing quality, automation, digital quality, risk-based digital assurance and proactive assurance.

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.