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Validation Engineer

LanceSoft Inc.
Plano, Texas, United States
November 05, 2018


Job description:

• 5 to 6 years of Process Validation (IQ, OQ & PQ) & test method validation experience or TMV

• 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 or design fixtures