Overview


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, No...