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 536/2014 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
For more information and a confidential discussion on the role please contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091 706718
