The Product Quality function partners with Engineering and cross-functional teams to enable the efficient and compliant release of a diverse range of products.
This role focuses on Delivery Excellence—driving the velocity of product releases in line with established strategies, while also contributing expertise to shape new strategies and improve design control processes, systems, and tools.
Responsibilities
- Project QA Planning
- Author and communicate QA plans to support new product implementations or changes to released products.
- Ensure QA plans align with ResMed’s Quality System, regulatory requirements (ISO13485, CFR820, MDSAP), risk management, and project timelines.
- Collaborate with Strategy team members when appropriate.
- Cross-Functional Engagement
- Actively participate in product cross-functional team (XFT) meetings with a positive, value-adding approach.
- Provide timely and targeted input to decisions, ensuring customer expectations for product quality and reliability are represented.
- Compliance & Risk Management
- Review product development deliverables for accuracy, efficiency, and compliance.
- Conduct ongoing compliance reviews, prepare reports, and approve product releases based on successful completion of requirements.
- Identify, evaluate, and escalate product quality, reliability, and field performance risks. Collaborate with XFT, QA, RA, and stakeholders to resolve risks effectively.
- Collaboration Across QA Functions
- Work with Post-Market, Supply Chain/Production, and RA colleagues to align updates and provide effective QA guidance.
- Support and/or manage responses to audit findings and CAPAs related to product development.
- Process & Training Enablement
- Identify and contribute to process improvement opportunities in collaboration with Delivery Enablement teams.
- Provide or facilitate training for Development teams on ResMed processes, Quality Systems requirements, best practices, CAPA, root cause analysis, problem solving, and risk assessment.
- Global Support
- Offer expertise and support across other Global Product Quality functions as required.
Qualifications & Experience
Required:
- Bachelor’s degree in Engineering, Computer Science, Science, or an equivalent discipline.
- Strong understanding of regulatory frameworks: MDSAP, FDA, MDD/MDR, ISO standards.
- Proven knowledge of ISO13485, ISO14971, and IEC62304 (software development).
- Familiarity with current good design practices for hardware and software in medical and related industries.
- Experience in product development and sustaining engineering environments.
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