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.
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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!
