Overview


The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, 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 of risk file documentation• Conduct Risk-based decision making and effective resolution of issues• Lead or support CAPAs as necessary<...