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IrishJobs
Quality Management Systems SpecialistIrishJobs • Galway, Galway, Ireland
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IrishJobs

Quality Management Systems Specialist

IrishJobs
  • IE
    Galway, Galway, Ireland
  • IE
    Galway, Galway, Ireland
Jetzt Bewerben

Über

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: Bachelors 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

TLNT1_IJ

  • Galway, Galway, Ireland

Sprachkenntnisse

  • English
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