Job title: Quality Complaint and Recall Administrator
Location: Fannin House, Leopardstown, D18
Reporting to: Quality & Regulatory Lead Medical Devices
Summary
The Quality Complaints & Recall Administrator is responsible for the coordination and administration of complaint handling, product recalls and Field Safety Corrective Actions (FSCAs) within a regulated pharmaceutical and medical device distribution environment. The role supports compliance with GDP, GMP, MDR and IVDR requirements through effective investigation, documentation, reporting and follow‑up of quality activities, while supporting Quality Management System processes and maintaining audit readiness.
Principal Duties And Responsibilities
Administration and coordination of the end‑to‑end complaint handling process
Coordination of product recalls and Field Safety Corrective Actions (FSCAs)
Ensure compliance with:
GDP, GMP, MDR and IVDR requirements
Vigilance and regulatory reporting requirements
Ensure complaints are assigned, investigated, and closed within defined timelines.
Escalate critical or potentially serious quality issues to the RP/QP/PRRC/Manager as appropriate.
Maintain inspection and audit readiness through accurate documentation and record management
Perform:
Complaint trending and data analysis
KPI monitoring and reporting
Training coordination for personnel on relevant quality processes
Liaise with:
Customers
Suppliers and manufacturers
Regulatory authorities
Internal stakeholders across all departments
Quality Management System Responsibilities
Administration of Quality Management System (QMS) processes related to complaints, FSCAs and recalls
Support quality processes including:
Change Control
Non-Conformance and CAPA management
Internal and external audits
Risk assessment and risk management activities
SOP authoring, review and document control administration
Completion of customer quality questionnaires and requests
Support regulatory activities including liaison with the Health Products Regulatory Authority and Medicines and Healthcare products Regulatory Agency
Support quality and compliance‑related projects
Preparation and submission of monthly, quarterly and annual KPI reports
Provide cross‑functional support and cover for other team members as required
Carry out additional duties appropriate to the role as assigned
Desirable Qualifications & Experience
Relevant third‑level qualification in Science, Quality, Regulatory Affairs or a related discipline
Knowledge of pharmaceutical and medical device terminology
Working knowledge of ISO 9001 quality systems
Experience working within GDP and/or GMP regulated environments
Experience using QMS software systems
Full Irish driving licence and access to transport desirable
Desired Characteristics
Proactive with strong organisational skills
Flexible and adaptable in a fast‑paced regulated environment
Strong problem‑solving and troubleshooting capability
Excellent written and verbal communication skills
Strong interpersonal skills with the ability to communicate effectively at all levels internally and externally
Ability to work independently while managing multiple priorities
High attention to detail and commitment to quality and compliance
FANNIN IS AN EQUAL OPPORTUNITY EMPLOYER
Although the above is a description of the requirements of your job, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.
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