Senior Product Quality Assurance Engineer - Medical Devices

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 is focused on Strategy & 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 released product in an efficient way that satisfies ResMed’s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), risk and project timing. 

• Apply balance of risk, regulatory intent and business needs to come to efficient and effective solutions. Define these strategies by close collaboration with stakeholders, considering benefit-risk, consistency across projects and starting with a “yes” mindset. 

• Regularly attend product cross functional team (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. 

• Actively engage, collaborate and build relationships with global stakeholders and leaders, including Engineering, QA, RA and other cross functional partners to understand business/department needs, risks and concerns.  Build this consideration into strategy planning and proposals to close gaps in an efficient, technical, and compliant manner

• Identify areas and opportunities to improve QMS processes

• Participate and lead support of internal and external audits within the relevant areas. Participate in relevant investigations as relate to design controls and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated. 

• To support projects across hardware & digital portfolios including but not limited to projects like NPI devices, SaMD, AI/ML models, Platform, IoT projects etc. 

Let’s talk about Qualifications and Experience  

Required (Qualifications/experiences that are an absolute must for the position) 

• 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. e.g. Agile, DevOps. 

• Maintain knowledge of current good design practice for hardware and software in both medical and adjacent industries. 

• Experience within product development 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!