Diverse Lynx
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 Assessment of applicability & criticality of GxP and 21 CFR Part 11.Creation and review of validation deliverables including but not limited. 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.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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 Assessment of applicability & criticality of GxP and 21 CFR Part 11.Creation and review of validation deliverables including but not limited. 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.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.