Quality Systems Specialist

The Quality Systems Specialist is responsible for the administration, maintenance, and continuous improvement of the Quality Management System (QMS) through the electronic Quality Management System (eQMS), ensuring compliance with ISO 13485, SFDA regulatory requirements, and Mölnlycke global standards.The role supports effective implementation and monitoring of document control, training compliance, change control, nonconformance reporting (NCR), corrective and preventive action (CAPA), internal audit coordination, supplier qualification support, and complaint tracking to maintain audit readiness and regulatory compliance under the direction of the Quality Operations Manager.Accountabilities1. QMS Administration (ISO 13485)Maintain and control QMS documentation within the electronic QMS system (eQMS)Ensure document lifecycle compliance (creation, review, approval, revision, and archival)Support ISO 13485 compliance and certification maintenance activities.2. Change Control, NCR and CAPA ManagementCoordinate the change control process from initiation to closureTrack and monitor CAPA effectiveness and closure timelinesEnsure NCR investigations are tracked and completed within defined timelinesMaintain CAPA and NCR metrics and escalation tracking.3. Internal Audit ProgramPlan and coordinate the internal audit scheduleConduct internal audits when qualified and assignedTrack audit findings, corrective actions, and closure statusSupport readiness for external audits and regulatory inspections.4. Supplier Quality ManagementSupport supplier qualification and periodic re-evaluation processesMaintain approved supplier list documentation and related recordsMonitor supplier performance documentation and metrics.5. Complaint HandlingSupport complaint registration and tracking of investigations and actionsEnsure complaint files are complete and maintained in a compliant mannerSupport regulatory documentation requirements when applicable.6- KPI & Reporting SupportGenerate weekly and monthly QMS dashboards and status reportsMonitor system KPIs (CAPA cycle time, audit findings status, overdue documents, training compliance status)Provide analysis and trends to the Quality Operations Manager.7- Regulatory & Compliance SupportSupport SFDA documentation alignment within the QMS frameworkMaintain traceability of Medical Device Marketing Authorization (MDMA) supporting documentationSupport preparation and coordination for external audits and inspectionsEmployee duties are not limited only to the above-mentioned Accountabilities; he/she may perform other duties as assigned.Job RequirementsEducationBachelor’s degree in Engineering, Pharmacy, Life Sciences, or related fieldExperience2–4 years experience in QMS administration within a regulated industryExperience supporting ISO 13485 audit readiness activitiesHands‑on experience coordinating CAPA and change control processesExperience supporting regulatory inspection preparation activitiesComputer SkillseQMS system proficiency (Qualio or equivalent)MS Office (Excel dashboards and reporting)ERP traceability awarenessDocument control systems and controlled templatesBasic data analytics and reportingLanguagesEnglish (fluent)Arabic (preferred)#J-18808-Ljbffr