Be the Guardian of Quality and Catalyst for Innovation in Digital Health
At ResMed, we are pioneers in cloud-connected medical devices that transform care for millions of people with sleep apnea, COPD, and other chronic conditions. Every product we release must meet the highest standards of safety, reliability, and efficacy to earn the trust of patients and clinicians worldwide.
We are seeking a strategic Product Quality Engineer to join our team. This is a unique role that sits at the heart of innovation, partnering directly with R&D and Engineering teams. You will be the crucial link that accelerates the release of groundbreaking products while ensuring unwavering compliance. Your work ensures that our passion for innovation is matched only by our commitment to quality.
Your Mission: Enable Speed and Ensure Safety
You will be the quality authority within cross-functional product teams, balancing the need for rapid development with the rigorous demands of the medical device industry. Your goal is not to slow down innovation, but to build quality and compliance into the fabric of our development process from the start.
Key Responsibilities:
- Strategic QA Partnership: Author and execute QA plans for new product development and sustaining engineering, ensuring they are aligned with ResMed’s Quality System and global regulations (ISO 13485, CFR 820, MDSAP).
- Cross-Functional Leadership: Act as the embedded Quality representative in product development teams, providing timely, value-added input to ensure customer expectations for quality and reliability are met without compromising project velocity.
- Proactive Risk Management: Identify, evaluate, and mitigate product quality and reliability risks early in the development lifecycle. Collaborate with Engineering, Regulatory Affairs (RA), and other stakeholders to implement effective solutions.
- Design Control Excellence: Review and approve key product development deliverables, ensuring accuracy, efficiency, and compliance. You are the gatekeeper for product release, confirming all requirements are successfully met.
- Process Improvement Champion: Identify and drive improvements to design control processes, systems, and tools in collaboration with Delivery Enablement teams, enhancing efficiency across the organization.
About You: The Ideal Candidate
You are a detail-oriented engineer with a passion for processes and a deep understanding of what it takes to build safe, effective medical devices.
Required Qualifications:
- Bachelor’s degree in Engineering, Computer Science, or a related scientific discipline.
- Strong understanding of medical device regulatory frameworks, including MDSAP, FDA, MDD/MDR, and ISO standards.
- Proven knowledge and practical application of ISO 13485, ISO 14971 (Risk Management), and IEC 62304 (Software Lifecycle).
- Experience in a product development or sustaining engineering environment within the medical device or a similarly regulated industry.
- Excellent communication and collaboration skills, with the ability to influence cross-functional teams.
Why This Role is a Career-Defining Opportunity:
- Sit at the Intersection of Innovation and Compliance: Work on the front lines of product development, shaping the future of digital health while ensuring patient safety.
- Become a Strategic Partner: Move beyond traditional auditing to become a valued advisor who enables engineering teams to move faster and smarter.
- Master a High-Demand Skill Set: Deepen your expertise in global medical device regulations and quality systems, building a highly valuable and transferable career profile.
- Impact Millions of Lives: The products you help bring to market will directly impact the health and well-being of patients around the globe.
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ResMed is an Equal Opportunity Employer. We are committed to a diverse and inclusive workplace and encourage applications from all qualified candidates.
