We are supporting a Galway based medical device client who are seeking a Senior Quality Assurance Engineer to support quality systems, regulatory compliance and clinical trial activities within a GMP-regulated environment.
Key Responsibilities
Maintain and improve the Quality Management System (QMS)Support regulatory inspections, audits and compliance activitiesAuthor and maintain quality documentation (procedures, specifications, labels)Provide QA oversight of product release and material dispositionLead and support quality improvement and change control initiativesSupport EU clinical trial supply in line with EU CTR 536/2014 and GMPManage investigations, complaints, CAPAs and technical agreementsConduct and support internal auditsLiaise with the Qualified Person to ensure ongoing IMP complianceRequirements
Degree in Engineering, Science or r...