QA AnalystContract – Hybrid – Dublin – 4 day weekAbout the CompanyOur client is a leading US healthcare company, with offices in Dublin city centre.About the PositionWe are seeking a Quality Assurance Analyst to support operations across Ireland and the UK. The role focuses on ensuring compliance with regulatory requirements, maintaining audit integrity, managing supplier quality, and supporting operational quality controls. This position is ideal for a quality professional with experience in regulated environments who thrives in both independent and cross-functional teamwork.Key ResponsibilitiesAudit Program SupportPlan, execute, and follow up on internal, external, and corporate audits.Maintain audit documentation and ensure timely closure of findings.Supplier Quality ManagementConduct supplier audits and evaluations.Maintain supplier qualification records to ensure compliance with standards and regulatory requirements.Non-Conforming Material OversightMonitor and manage non-conforming materials.Partner with cross-functional teams to drive timely resolution of issues.CAPA & Change ControlManage Corrective and Preventive Action (CAPA) activities.Support and document change control processes.Quality DocumentationDraft, maintain, and update SOPs, procedures, and other controlled documents.Training & ComplianceSupport quality system training activities, ensuring alignment with compliance requirements.Operational Quality SupportAssist with incoming inspection processes.Monitor environmental conditions and ensure compliance with quality standards.Support calibration management by scheduling, documenting, and tracking compliance of equipment.Experience/RequirementsProven experience in quality assurance within medical devices, healthcare technology, or other regulated industries.Strong knowledge of ISO 13485:2016 and related regulatory frameworks (EU MDR, EU MDD, UK MDR).Certified Lead Auditor for ISO or equivalent).Familiarity with FDA QMSR and its alignment with ISO standards.Experience in supplier quality management and risk assessments.Strong documentation, audit, and compliance tracking skills.Ability to work independently and collaboratively across regions.Key SkillsInternal and supplier auditing (planning, execution, and follow-up).Supplier risk assessment and qualification management.CAPA management and timely closure of actions.Documentation control and SOP management.Non-conformance monitoring and resolution.Knowledge of environmental monitoring in regulated facilities.Calibration management oversight.Strong analytical, problem-solving, and communication skills.Remuneration PackageA strong rate is on offer, this is a hybrid role and working a 4 day week.ContactPlease contact Derek Smyth on or email or simply click the apply button.To view all live jobs with Brightwater and market insights, please visit our website