Quality Specialist

About the Role

Aljeel Medical is seeking a Quality Specialist to join its team in Riyadh, Saudi Arabia. This is a full-time position requiring 2-5 years of experience. The primary responsibility of this role is to serve as the dedicated SFDA post-market vigilance officer, overseeing the day-to-day operations of the post-market surveillance and vigilance system for medical devices distributed within the Kingdom.

Key Responsibilities

• Act as the primary focal point for SFDA post-market surveillance (PMS) and vigilance activities for all distributed medical devices.
• Receive, log, triage, and investigate customer complaints and reported incidents, coordinating with manufacturers and internal departments.
• Assess the reportability of adverse events and submit reports to SFDA via NCMDR channels within required timelines, maintaining a complete and auditable vigilance file.
• Coordinate and execute recalls and Field Safety Corrective Actions (FSCA), including distributing Field Safety Notices (FSN), tracking affected stock, performing quantity reconciliation and effectiveness checks, and preparing closure reports.
• Monitor manufacturer safety communications, FSNs, and regulatory alerts, initiating corresponding internal actions.
• Maintain complaint and vigilance trending data, escalating signals and repeated issues to the Quality Manager for CAPA and risk review.
• Support the handling of expired, damaged, and non-conforming products in line with internal SOPs and SFDA requirements.
• Prepare periodic vigilance and post-market surveillance reports and maintain records for SFDA inspection.

Quality Management System Support

As a secondary responsibility, the Quality Specialist will support the Quality Manager in maintaining the ISO 13485:2016 Quality Management System. This includes:

• Controlling documented information (SOPs, forms, records) under the QA-SOP-XXX framework.
• Assisting in raising, tracking, and closing CAPAs and nonconformities, and preparing data for Management Review.
• Participating in internal and supplier audits as an auditor or auditee support, and helping to follow up on audit findings to closure.
• Supporting supplier quality tasks, incoming inspection records, and storage/warehouse quality checks (temperature, segregation, traceability).
• Contributing to customer satisfaction monitoring and internal quality-improvement initiatives.
• Providing general support to the Quality Manager on quality, compliance, and regulatory tasks as assigned.

Required Knowledge of SFDA Regulations

• PMS & Vigilance: Post-market surveillance and adverse event reporting requirements, timelines, and NCMDR reporting channels.
• Recalls & FSCA: Field Safety Corrective Actions, Field Safety Notices, and recall execution and reconciliation.
• MDMA: Awareness of Medical Device Marketing Authorization and product listing status as it relates to distributed devices.
• MDS-G: General awareness of relevant SFDA guidance documents and Good Distribution/Storage Practice.

Key Working Relationships

The Quality Specialist will interact with various internal and external stakeholders to fulfill the responsibilities of the role.

• Internal: Quality Manager, Regulatory Affairs, Warehouse & Logistics, Commercial/Sales, Customer Service.
• External: SFDA/NCMDR, principal manufacturers, Authorized Representatives, customers (hospitals & healthcare providers).