| Role Description: | ? Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.? Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.? Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.? Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.? Creation and review of validation deliverables including but not limited to? Requirement Specifications (User, Functional)? Plan? Qualification Protocol (Installation, Operational, Performance)? Reports (Summary, Exception) of protocol execution? Traceability Matrix? Periodic Reviews? System Retirement/Decommissioning? Execution of Dry/Test protocol run ? Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions? Perform System Retirement/Decommissioning of systems not in business? Work closely with software development and IT teams to establish best practices for quality and compliance.? Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.? Drive continuous improvement initiatives in software development processes, ensuring alignment with the company?s quality management system. |
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