Lead Internal QA Auditor - Medical Device QMS Expert

Posted 14 days 9 hours ago by Cook Medical Incorporated

Permanent
Full Time
Other
Limerick, Limerick, Ireland
Job Description

Cook Medical Incorporated is seeking a Quality Assurance professional to oversee the CMEU QMS, lead internal audits, and drive CAPA initiatives. The role requires experience with ISO13485, EU MDR 2017/745, and FDA QSR, with lead auditor credentials preferred.

You will collaborate across departments, ensure regulatory compliance, and support training, KPI reporting, and management reviews. Travel on company business is expected.