Quality Systems Specialist

<div><p>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.</p><p>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.</p><h3>Accountabilities</h3><h3>1. QMS Administration (ISO 13485)</h3><ul><li>Maintain and control QMS documentation within the electronic QMS system (eQMS)</li><li>Ensure document lifecycle compliance (creation, review, approval, revision, and archival)</li><li>Support ISO 13485 compliance and certification maintenance activities.</li></ul><h3>2. Change Control, NCR and CAPA Management</h3><ul><li>Coordinate the change control process from initiation to closure</li><li>Track and monitor CAPA effectiveness and closure timelines</li><li>Ensure NCR investigations are tracked and completed within defined timelines</li><li>Maintain CAPA and NCR metrics and escalation tracking.</li></ul><h3>3. Internal Audit Program</h3><ul><li>Plan and coordinate the internal audit schedule</li><li>Conduct internal audits when qualified and assigned</li><li>Track audit findings, corrective actions, and closure status</li><li>Support readiness for external audits and regulatory inspections.</li></ul><h3>4. Supplier Quality Management</h3><ul><li>Support supplier qualification and periodic re-evaluation processes</li><li>Maintain approved supplier list documentation and related records</li><li>Monitor supplier performance documentation and metrics.</li></ul><h3>5. Complaint Handling</h3><ul><li>Support complaint registration and tracking of investigations and actions</li><li>Ensure complaint files are complete and maintained in a compliant manner</li><li>Support regulatory documentation requirements when applicable.</li></ul><h3>6- KPI&Reporting Support</h3><ul><li>Generate weekly and monthly QMS dashboards and status reports</li><li>Monitor system KPIs (CAPA cycle time, audit findings status, overdue documents, training compliance status)</li><li>Provide analysis and trends to the Quality Operations Manager.</li></ul><h3>7- Regulatory&Compliance Support</h3><ul><li>Support SFDA documentation alignment within the QMS framework</li><li>Maintain traceability of Medical Device Marketing Authorization (MDMA) supporting documentation</li><li>Support preparation and coordination for external audits and inspections</li></ul><p>Employee duties are not limited only to the above-mentioned Accountabilities; he/she may perform other duties as assigned.</p><h3>Job Requirements</h3><h3>Education</h3><ul><li>Bachelor’s degree in Engineering, Pharmacy, Life Sciences, or related field</li></ul><h3>Experience</h3><ul><li>2–4 years experience in QMS administration within a regulated industry</li><li>Experience supporting ISO 13485 audit readiness activities</li><li>Hands‑on experience coordinating CAPA and change control processes</li><li>Experience supporting regulatory inspection preparation activities</li></ul><h3>Computer Skills</h3><ul><li>eQMS system proficiency (Qualio or equivalent)</li><li>MS Office (Excel dashboards and reporting)</li><li>ERP traceability awareness</li><li>Document control systems and controlled templates</li><li>Basic data analytics and reporting</li></ul><h3>Languages</h3><ul><li>English (fluent)</li><li>Arabic (preferred)</li></ul></div>#J-18808-Ljbffr