QA Engineer - Manufacturing (Fixed Term)
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. If this sounds like the workplace for you, apply now!