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Skills:
Iso 14971, Iso 13485, Fmea, ISO IATF16949, PCBA and Box Build for Medical Devices, Spc, Test Method Validation, validation protocols for medical devices, Control Plan, FDA 21 CFR Part 820, 8D, Product Quality Plan, IQ OQ PQ process, Minitab, advanced Microsoft Excel, QMSR, utility validation
Skills:
8D methodology, Lean, First Article Inspection, Fmea, Inspection Plan, Spc, IPC standards, Kaizen, Six Sigma, Pmp, Work Instruction, Quality control plan
