QA Engineer - PFT (12-Month Contract)

ResMed Inc; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

ResMed Inc in Johor Bahru, Malaysia, invites applications for a QA Engineer - PFT on a 12-month contract. You will support manufacturing to achieve quality and reliability, participate in new product introductions, and ensure compliance to QA standards.

The role emphasizes quality by design, risk-based planning, and data-driven decision making, collaborating with Manufacturing, Engineering and Operations to drive continuous improvement and launch readiness.

Qualifications

• Bachelor's degree in Engineering or Science is required.
• 3+ years' experience in a regulated volume manufacturing environment.
• Experience with Quality Systems, risk management and process validation.
• Ability to use quality data and manufacturing information to identify trends and support decisions.

Responsibilities

• Support manufacturing to achieve quality, availability and value objectives.
• Participate in new product/process introductions with QbD and risk-based planning.
• Support manufacturing readiness activities, including validation, risk assessments and CSV/CSA deliverables.
• Apply QA standards and drive standardization across manufacturing teams.
• Use data and audit findings to identify trends and drive preventive actions.

Skills

Quality systems

Risk management

Process validation

Root cause analysis

Data-driven decisions

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

MES

CSV/CSA

AI tools

Job description

## QA Engineer - PFT (12-Month Contract)Apply: Johor Bahru, Malaysia: Full time: Posted Today: JR\\_054146**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. **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. #LI-APACJoining 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, apply now!