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 activities Author and maintain quality documentation (procedures, specifications, labels) Provide QA oversight of product release and material disposition Lead and support quality improvement and change control initiatives Support EU clinical trial supply in line with EU CTR ******** and GMP Manage investigations, complaints, CAPAs and technical agreements Conduct and support internal audits Liaise with the Qualified Person to ensure ongoing IMP compliance Requirements Degree in Engineering, Science or related discipline (Master's/MBA advantageous) 5+ years' QA/QE experience in FDA, GMP or ISO-regulated industries Trained auditor with strong inspection readiness experience Knowledge of clinical trial and medical device regulatory requirements Experience with Lean, Six Sigma and continuous improvement Strong communication, problem-solving and stakeholder management skills