Process Engineer (Auburn, AL) F/T. Executes numerous functions w/in an ISO 13485 registered Quality Mgmt System. Responsible for QA activities involving a variety of different products, assemblies, & components using various mfg & assembly processes as related to a medical device contract mfg. Perform advanced quality planning functions, incl Gage R&R & MSA, drawing reviews, capability studies, production documentation approval, inspection plans. Perform Statistical Analysis, incl SPC, ANOVA, T-Test, F-Test, capability studies. Lead pFMEA sessions & lend support for dFMEA meetings. Author Level 2 & Level 3 SOPs & Work Instructions. Responsible for QMS documentation review & mgmt (Device Master Records, Device History Records, CAPA & Complaint system). Bach's deg in Industrial Engg, or I
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