Heidi seeks a Design Quality & Compliance Engineer to ensure software design and development meet global medical device standards (IEC 62304, ISO 14971, ISO 13485) within an agile environment. Reporting to Legal & Regulatory Affairs, you’ll collaborate with Engineering and Product to embed compliance in rapid-paced delivery. You will drive design control, manage technical documentation, risk management files, verification and validation, and audits.
📌 SaMD Design Quality (Canberra)
🏢 Health Data Innovations
📍 Canberra
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