COOK
Job Location : Bloomington,IN, USA
Posted on : 2025-08-06T17:24:23Z
Job Description :
The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing. Responsibilities - Perform work per external and internal quality standards.- Interface with internal and external groups on quality-related issues.- Support product development and transfer to manufacturing.- Facilitate development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)- Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.- Plan, review, and approve change requests.- Execute risk assessment as needed and facilitate development and completion of risk file documentation.- Conduct Risk-based decision making and effective resolution of issues.- Lead or support CAPAs as necessary. - May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)- Drive continuous improvement effo...Quality Engineer, Manufacturing, Continuous Improvement, Engineer, Quality, Senior, Technology
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