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Skaneateles Falls NY Job Description: >> Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. >> Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. >> Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define software validation requirements and risk-based testing strategies. >> Perform IQOQPQ for ATE systems and ensure traceabilit
Contract, Third Party
$50 - $50