OverviewA leading regulated manufacturing organisation is seeking a Senior Quality Engineer – Compliance for a 12-month contract. This is a key technical role focused on ensuring manufacturing activities meet current global regulatory standards, including ISO 13485:2016 and EU MDR.The successful candidate will play a central role in risk management, change control, and production quality support, acting as a key liaison between Quality and Operations.Location: Mayo, IrelandSector: Medical Devices / Regulated ManufacturingDiscipline: Quality Assurance / ComplianceKey ResponsibilitiesRisk ManagementLead and maintain risk management documentation, including pFMEAsIdentify, assess, and mitigate potential failure modes across processesProduction Quality SupportProvide on-the-floor QA support to manufacturing teamsManage non-conformances and lead root cause investigationsDrive implementation of effective CAPAs (Corrective and Preventive Actions)Audit & ComplianceSupport internal and external auditsEnsure compliance with cGMP and regulatory requirementsMaintain accurate and audit-ready documentationData Analysis & Continuous ImprovementAnalyse process data using statistical tools (e.g. Minitab, Excel)Identify trends and support data-driven improvementsContribute to process optimisation and continuous improvement initiativesAdditional DutiesSupport broader Quality Assurance activities as requiredRequirementsEssentialBachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related) or Life SciencesMinimum 2 years’ experience in Quality Assurance or Validation within medical devices or a regulated industryStrong knowledge of:ISO 13485EU MDRISO 14971Experience with root cause analysis tools (e.g. 5 Whys, Fishbone, FMEA)Strong analytical and problem-solving capabilitiesExcellent technical writing and communication skillsProficiency in tools such as Excel, Minitab, Power BI or equivalentDesirableASQ Certified Quality Engineer (CQE) or equivalentInternal or Lead Auditor certificationLean / Six Sigma certificationBroader knowledge of international medical device regulationsKey CompetenciesHigh attention to detail and strong quality mindsetAbility to manage multiple priorities in a fast-paced environmentStrong cross-functional collaboration skillsProactive, self-driven, and continuous improvement focusedEqual Opportunity StatementAll applications will be treated in strict confidence. Opportunities are offered based on merit, skills, and experience, without regard to protected characteristics.
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