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• Review all project / program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
• Provides direction and leadership for verification and validation of non-product software, products software, software tools and components.
• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation. Collaborate with project / program teams to ensure software deliverable comply with RADS procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Medical Device Regulation (MDR), and applicable guidance.
• Provide Quality representation during software problem resolution.
• Participate in technical design reviews and project phase reviews.
• Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.
• Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.
• Support internal audits and external audits by regulatory agencies, as required.