Role responsibilities
Lead software assurance activities throughout the medical device software lifecycle, ensuring compliance with regulatory requirements and industry standards. Conduct audits, review documentation, and provide insights on project status and quality metrics.
Requirements
Candidates must have a Master's or Bachelor's degree in relevant fields with significant experience in software quality assurance within the medical device, aerospace, or automotive industries. Knowledge of medical device regulations and software engineering best practices is essential.
Key skills
Software Quality Assurance, Regulatory Compliance, Risk Management, Test Readiness, C Language, Embedded Systems, IoT, Bluetooth, Wi-Fi, Cybersecurity, Problem Solving, Communication, Attention to Detail, Interpersonal Skills, Configuration Audits, Quality Metrics
Keywords
Software Engineering, Quality Assurance, Medical Device, Regulatory Compliance, FDA, EU MDR, ISO 13485, IEC 62304, SaMD, SiMD, Embedded Software, Cybersecurity, Risk Management, Configuration Audits, Test Procedures, Documentation, Healthcare Technology