Continued from H.10B Requires a Masters degree in Quality Engineering, Manufacturing Engineering or related engineering field willing to accept foreign education equivalent plus three 3 years of experience in a manufacturing or quality engineering role developing business processes and quality systems enhancements within regulated industry or, alternatively, a bachelors degree in Quality Engineering, Manufacturing Engineering or related engineering field willing to accept foreign education equivalent plus five 5 years of experience in a manufacturing or quality engineering role developing business processes and quality systems enhancements within regulated industry. Experience must include NPI Quality for instrumentation hardware and qualification; application of production and process controls including process validation, process control plans and statistical process control; developing business processes and quality systems enhancements product design through manufacturing in a mature industry that has stringent quality regulations; risk management and design control principles; representing department during quality system audits; product mechanical evaluation testing and GDT; conducting advanced statistical CPK analysis; injection plastic molded parts, product mechanical evaluation, testing and GDT; and working with QMS standards ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820.

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