Clinical Lab Technologist

4 weeks ago

Franklin Lakes, United States Insight Global Full time

Job Description/Day-to-Day:IG is seeking lab specialist that will be focused on supporting the development and validation of innovative in-vitro diagnostic (IVD) devices. This position plays a key role in ensuring product safety, performance, and regulatory compliance, while collaborating across departments to drive innovation.Support the design, testing, and reporting of new or updated IVD devices.Operate and maintain a variety of lab instruments and platforms.Lead and manage clinical studies and complaint investigations.Conduct Clinical Software Validations (CSV) and instrument qualification (IQ/OQ/PQ).Apply quality and regulatory standards (GLP, GCP, ISO) to lab processes.Troubleshoot technical issues using scientific judgment.Work cross-functionally with teams in manufacturing, marketing, quality, and regulatoryMust Have Skills & Experience5 years' experience in a Clinical Laboratory environmentManual Differential testing experienceUrinalysis testing experienceBS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology or health related field

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