Overview


The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, m Next (https://cookmedical.icims.com/icims2/servlet/icims2?module=AppProfileEdit&action=switchEditTab&hashed=709002758&type=next#!) anufacturing, post-market surveillance, and/or CAPA.


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 nonconformance/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 o...