Summary
A Quality Management Systems Specialist is required for a medical device company in Galway.
The successful candidate will support the execution, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable regulatory requirements and quality standards.
The role will work cross-functionally to support quality system activities, regulatory compliance, audit readiness, and continuous improvement initiatives.
This is a fully onsite position.
Responsibilities
Support the maintenance, execution, and continuous improvement of the Quality Management System (QMS)
Lead and coordinate CAPA activities, including investigations, root cause analysis, implementation, and effectiveness verification
Act as subject matter expert for change control activities, ensuring appropriate risk assessments and regulatory impact assessments are completed
Plan, schedule, support, and execute internal audit programmes in line with applicable quality standards
Support regulatory inspections, customer audits, and external audits, including preparation, hosting activities, and follow-up actions
Support management review activities through preparation, analysis, and presentation of quality system metrics and performance data
Maintain and improve documentation control processes to ensure compliance and consistency across QMS documentation
Analyse quality data, including complaints, non-conformances, CAPA trends, and other quality metrics to identify improvement opportunities
Support digitalisation and automation initiatives within quality systems and electronic quality management tools
Support implementation and assessment of new technologies and systems to improve QMS effectiveness and compliance monitoring
Ensure alignment with applicable regulatory requirements and quality standards through gap assessments and remediation activities
Support the development and delivery of training programmes to ensure awareness and compliance across the organisation
Support risk management activities, ensuring risks are appropriately identified, assessed, mitigated, and monitored
Collaborate with supplier quality teams to support supplier controls and quality agreements
Support continuous inspection readiness activities across all quality systems processes
Work closely with Manufacturing, Engineering, Regulatory, R&D and other functions to ensure effective quality system implementation
Qualifications & Experience
Bachelor's degree in Engineering, Science, Technical Discipline or related field preferred
Minimum 2 years' experience within Quality, Regulatory Compliance, or a related environment
Previous experience within the Medical Device industry is essential
Strong understanding of quality management systems and global regulatory requirements, including FDA, ISO standards, and EU regulations
Experience supporting quality system elements such as CAPA, change control, non-conformance management, validation activities, and risk management
Experience supporting internal and external audits and inspection readiness activities
Familiarity with quality tools and methodologies such as root cause analysis, FMEA, risk management, Six Sigma, and statistical analysis techniques
Experience using enterprise quality systems and ERP systems such as SAP, EtQ, or similar is desirable
Experience supporting Software as a Medical Device (SaMD) and Class II medical devices would be advantageous
Good working knowledge of Microsoft Office applications
#J-*****-Ljbffr