Job Summary
Product Quality supports and collaborates with the Engineering group and Cross Functional teams to enable a diverse range of product releases in an efficient and compliant way.
This role will be focused on Delivery Excellence - enabling velocity of product releases in alignment with established strategies, while also providing expertise to inform new strategies and improve design control processes, systems and tools.
Let’s talk about Responsibilities
Author and communicate the project QA plan to enable new product implementation or changes to release product in an efficient way that satisfies ResMed’s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), risk and project timing. Where appropriate, the QA plan will be developed in conjunction with the Strategy team member.
Regularly attend product XFT meetings and actively participate in a positive, value-add manner.
Review Product Development deliverables to ensure they are completed accurately and efficiently. Conduct ongoing compliance reviews and provide reports as requested. Approve product releases based on successful completion of deliverables and compliance reviews.
Advocate customer expectations for product quality and reliability, by providing effective, targeted and timely input to decisions. Also identify, evaluate and escalate risks during development that could impact product quality/reliability/field performance. Effectively communicate these concerns and lead or participate in resolution 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 or participate in resolutions of quality risks with the XFT, QA, RA and other stakeholders.
Within the scope of the project, collaborate with other QA (e.g. Post Market and Supply Chain/Production) and RA team members to provide updates and support effective QA guidance to the project teams.
Manage or support the response to audit findings and CAPAs in the Product Development area.
Identify opportunities for process improvements and collaborate with the “Delivery Enablement” team member/s to define the improvement opportunities and in some cases, participate in implementation.
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.
Provide expertise to and support other Global Product Quality as required.
Let’s talk about Qualifications and Experience
Required
Bachelor Degree in Engineering, Computer Science, Science or other tertiary qualifications deemed appropriate for this position.
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.
Experience within product development & sustaining environment
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!
