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Validation Engineer

Job Title: Validation Engineer Location: Sylmar, CA Duration: FTE Keywords: Validation Engineer, IQ/OQ/PQ, test method validation (TMV), medical device exp Mandatory Skills: ISO 13485 & ISO 14971, Hazard Analysis, DFMEA, PFMEA, UFMEA, Post market complaint data analysis and updating risk files Job Description: 5 to 6 years of Process Validation (IQ, OQ & PQ) & test method validation experience Experience in process characterization, Gage R&R studies Knowledge in Statistical data analysis & Minitab Experience in working with Medical devices (especially implantable class III products like Pacemekers, ICD, CRTD etc) manufacturing ISO 13485, 21 CFR 820 & Med dev Knowledge in Risk Management per ISO 14971 PFMEA Knowledge in change control process Knowledge in fixture design

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