Job Description

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.
Let’s talk about the team
The Product Quality team at ResMed is focussed on delivering the best quality products for our customers. The Product Quality team supporting Product Development are a truly diverse and global team – with global team members to support different product types with hardware, electrical, embedded and standalone software.
We love partnering with ResMed’s innovative Product Development teams, to ensure the highest level of quality and compliance standards are delivered, whilst continually evolving the function to ensure we remain "best in class”.
Let’s talk about the role

• Develop project QA plan to enable new product implementation or changes to released product in an efficient way that satisfies ResMed’s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), risk and project timing.
• Advocate customer expectations for product quality and reliability, by providing effective, targeted and timely input to decisions. Also identify, evaluate and escalate risks that could impact product quality/reliability/field performance.
• Effectively communicate concerns and lead resolutions of product quality/reliability risks with the XFT, QA, RA and other stakeholders.
• Review and evaluate quality risks associated with projects’ compliance. Recognise quality risks that require escalation. Effectively communicate concerns and lead resolutions of quality risks with the XFT, QA, RA and other stakeholders.
• Review Product Development deliverables to ensure they are completed accurately and efficiently.
• Manage or support the response to audit findings and CAPAs in the Product Development area.
• Across projects, collaborate with other QA (including Service and QA PFT) and RA team members to provide updates and support effective QA guidance to the project teams.
• Across projects, actively identify process improvements in collaboration with the Development teams and other QA XFT team members and drive implementation of changes with stakeholders.
• Identify and provide or facilitate training of the Development teams. Topics may include ResMed’s processes and systems, Quality Systems requirements for medical devices, best quality practices, CAPA, root cause analysis, problem solving, quality risk assessment.
• Lead the roll out and adoption of new quality processes or systems in Product Development.
• Engage with Development and business stakeholders to build relationships to influence and drive quality considerations into key decisions.
• For software only products – extend the above responsibilities to deployment and production support activities as they relate to the specific project.

Let's talk about you

• Degree in Engineering, Computer Science, Science or other tertiary qualifications deemed appropriate for this position.
• Minimum of 5 years’ relevant experience or equivalent demonstrated ability in a product development environment.
• 5 years’ experience in a medical device industry, or other ISO or regulated environment.
• Demonstrated ability to take initiative and work with minimal supervision to achieve role responsibilities effectively.
• If supporting software development teams – experience with IEC62304 and different software development methodologies, e.g. Agile, DevOps.
• Experience in Manufacturing and Project management will be a plus.
• Strong understanding of MDSAP, FDA, MDD/MDR and ISO Quality standards/regulations, including ISO13485, ISO14971 and IEC62304 for software development.
• Maintain knowledge of current good design practice for hardware and software in both medical and adjacent industries.
• Understanding of Design for Six Sigma or equivalent quality principles.
• Excellent people and negotiation skills.
• Basic Auditing skills.

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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!