QA Engineer - PFT (12-Month Contract)

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

The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.

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.

Pharmaceuticals, Biotechnology & Medical Devices 51-100 employees

ResMed is a global leader in the design, manufacture and distribution of innovative products for the diagnosis, treatment and management of sleep disordered breathing and respiratory disorders. The company has experienced sustained and significant growth since inception and now employs approximately 2500 people world-wide. The global business environment is becoming increasingly competitive, which is resulting in a greater emphasis on innovation and a cost effective approach to achieving market leadership through technological advances.

ResMed is a global leader in the design, manufacture and distribution of innovative products for the diagnosis, treatment and management of sleep disordered breathing and respiratory disorders. The company has experienced sustained and significant growth since inception and now employs approximately 2500 people world-wide. The global business environment is becoming increasingly competitive, which is resulting in a greater emphasis on innovation and a cost effective approach to achieving market leadership through technological advances.