Position Overview
Overview
The Quality Engineer is a vital member of our quality team, responsible for ensuring the integrity and compliance of our medical devices throughout the product lifecycle. This role involves leading quality assurance activities, supporting continuous improvement initiatives, and collaborating across functions to uphold Cook Medical’s high standards of quality and regulatory compliance.
Responsibilities
Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and other applicable standards.Act as the primary contact for quality issues, interfacing with internal teams and external stakeholders.Conduct risk assessments and develop risk management documentation, including FMEAs.Lead investigations into product non-conformances and complaints, performing root cause analysis and implementing CAPAs.Review and approve change requests, ensuring compliance ...