QA Engineer - PFT (12-Month Contract)

Resmed; Johor Bahru; On-site; MYR 80,000 - 140,000; Full time

Job summary

ResMed is seeking a Quality Engineer to support manufacturing quality objectives in a regulated environment in Johor Bahru, Malaysia. You will contribute to new product introductions, validation activities, and digital assurance deliverables.

The role involves applying Quality by Design, risk-based planning and structured problem solving to ensure compliant processes and continuous improvement across manufacturing teams.

Qualifications

• Bachelor's degree in Engineering or Science
• Experience in a regulated volume manufacturing industry
• Experience in Quality Systems, Manufacturing Quality, risk management, process validation and structured root cause solving
• Ability to apply Quality Engineering methods to support manufacturing quality delivery
• Independent and proactive learner with ability to work under guidance while building digital quality & QA capability
• Ability to use quality data to identify trends and support decisions
• Good planning and organisational skills
• Strong communication and collaboration skills with manufacturing, engineering and quality partners

Responsibilities

• Support Manufacturing to achieve Quality, Availability and Value objectives using established Quality Engineering methods.
• Participate in new product/process introduction with Quality by Design and risk-based planning.
• Support readiness activities including validation, risk assessments, and launch learning.
• Apply QA standards and tools to drive consistency and adoption across manufacturing teams.
• Use data and trends to identify issues and recommend preventive actions.
• Contribute to continuous improvement of manufacturing quality systems and practices.
• Provide quality guidance through training, coaching and data-driven decision making.
• Partner with Manufacturing Engineering and Operations to consider Quality early in changes.
• Participate in digital quality/automation pilots and engage CSV/CSA expertise where applicable.
• Foster a quality culture through education and day-to-day engagement.
• Ensure compliance to QMS and regulatory standards; perform audits as required

Skills

Quality Engineering methods

Root cause analysis

Data-driven decision making

Cross-functional collaboration

Structured problem solving

Quality by Design

Digital assurance

Regulatory awareness

Education

Bachelor's degree in Engineering or Science

Tools

CSV/CSA

MES

AI tools

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, standardization 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.

Required

Let's talk about Qualifications and Experience

• 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. If this sounds like the workplace for you,