Senior Development Quality Engineer position to perform quality engineering activities & support manufacturing process development, qualification, V&V for new medical device product commercialization & product changes.
Requirements:
Masters or foreign equivalent in Industrial Engineering, Manufacturing Engineering or in related engineering field of study. Must possess professional experience in: (1) developing product quality plans, documents & systems by creating product specifications, quality specifications & quality plans; (2) utilizing tools, including Gage R&R, Cp/Cpk & SPCs; methodologies, including Six Sigma & Lean Manufacturing; & manufacturing concepts, including Value Stream Mapping, 5S & Visual Workplace; (3) Design Verification activities, identifying root causes & implementing corrective/preventative actions; (4) writing, executing & analyzing various types of process validation protocols (IQ, OQ, PQ, PPQ); & (5) compliance with FDA 21 CFR 820 & ISO 13485.
40 hrs/wk. An EOE.
To apply:
Send resumes to: Abbott Laboratories, Attn: Elvia Salzar, Willis Tower, 233 S. Wacker Drive, Floor 25, Dept. 32, Chicago, IL 60606. Refer to Ad Code: SJM-0037-ES.
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