Katalyst Healthcares and Life Sciences
Validation Engineer
Katalyst Healthcares and Life Sciences, Santa Clara, California, us, 95053
Roles & Responsibilities:
Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing, dev, maintenance.) Strong multitasking and prioritization. Interpret and respond to regulatory & customer requirements quickly. Work in teams and solve problems independently. Validation Responsibilities: Plan, schedule, organize validation for new and existing applications from: Manufacturing. Quality Control. Clinical. R&D departments. Draft, review & approve. User Requirements (URS), Functional Specifications, Design Specs. Configuration Specs. Deviation and non-conformance reports. SOPs related to QMS. Prepare & review audit trails, risk assessments, GxP applicability. uthor Validation Plans & Summary Reports. Perform traceability matrix creation. Cross-Department Interaction. Interact with stakeholders for cooperation and validation approvals. Work closely with Quality and Compliance teams. Participate in audits - internal, vendor, and regulatory. Regulatory Alignment. Ensure compliance with internal SOPs, forms, and Periodic Review procedures. Conduct QMS and regulatory training.
Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing, dev, maintenance.) Strong multitasking and prioritization. Interpret and respond to regulatory & customer requirements quickly. Work in teams and solve problems independently. Validation Responsibilities: Plan, schedule, organize validation for new and existing applications from: Manufacturing. Quality Control. Clinical. R&D departments. Draft, review & approve. User Requirements (URS), Functional Specifications, Design Specs. Configuration Specs. Deviation and non-conformance reports. SOPs related to QMS. Prepare & review audit trails, risk assessments, GxP applicability. uthor Validation Plans & Summary Reports. Perform traceability matrix creation. Cross-Department Interaction. Interact with stakeholders for cooperation and validation approvals. Work closely with Quality and Compliance teams. Participate in audits - internal, vendor, and regulatory. Regulatory Alignment. Ensure compliance with internal SOPs, forms, and Periodic Review procedures. Conduct QMS and regulatory training.