Role: Computer System Validation Engineer Location: Santa Clara, CA (Onsite) Job type: Contract Job 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 by assessing applicability and criticality of GxP and 21 CFR Part 11. Create and review validation deliverables including but not limited to: Requirement Specifications (User, Functional) Plan Qualification Protocols (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution Traceability Matrix Periodic Reviews System Retirement/Decommissioning Execute Dry/Test protocols, conduct periodic reviews to determine if systems are in a validated state, and take appropriate actions. Perform system retirement/decommissioning of systems not in use. Collaborate 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, aligning with the company's quality management system. Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without discrimination. We evaluate applicants solely based on their ability, competence, and proven capability to perform the functions outlined in the role. We promote and support a diverse workforce across all levels in the company. #J-18808-Ljbffr Diverse Lynx
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