QA Engineer - Manufacturing Quality & Process Improvement

ResMed (Malaysia) Sdn Bhd (MY); Kulai; On-site; MYR 67,000 - 134,000; Full time

Job summary

ResMed (Malaysia) Sdn Bhd (MY) is seeking a Manufacturing Quality Engineer to design, implement, and monitor quality control programs in a regulated manufacturing environment. You will support quality planning, risk assessments, and validation activities across new product introductions and manufacturing readiness.

The role emphasizes applying Quality by Design, data-driven decision making, and continuous improvement to enhance Right First Time performance and reduce repeat quality issues.

Qualifications

• 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, 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.
• Experience in Quality and/or Regulatory positions in the medical device industry is preferred.
• Demonstrated capability in using AI tools or data-driven technologies for efficiency improvement, quality insights and decision support.
• Exposure to MES/digital quality, CSV/CSA, automation, advanced analytics, Quality by Design or advanced quality planning.

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.
• 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.

Skills

Quality engineering methods

Root cause analysis

Data-driven decisions

Interpersonal skills

Education

Bachelor's degree in Engineering or Science

Tools

MES

CSV

CSA

AI tools

Job description

ResMed (Malaysia) Sdn Bhd (MY) is seeking a Manufacturing Quality Engineer to design, implement, and monitor quality control programs in a regulated manufacturing environment. You will support quality planning, risk assessments, and validation activities across new product introductions and manufacturing readiness.

The role emphasizes applying Quality by Design, data-driven decision making, and continuous improvement to enhance Right First Time performance and reduce repeat quality issues.