Quality Specialist

1. JOB PURPOSE:The Quality Specialist serves as the company’s dedicated SFDA post-market vigilance officer, responsible for theday-to-day operation of the post-market surveillance and vigilance system for medical devices distributed in theKingdom. The role ensures that complaints, adverse events, recalls and Field Safety Corrective Actions are captured, investigated and reported to the SFDA within regulatory timelines, and acts as a first-line focal point with the Authority. As a secondary responsibility, the role supports the Quality Manager in maintaining the ISO13485:2016 Quality Management System, including documentation, CAPA, audits and general quality activities.2. ROLE AND RESPONSIBILITIES:A. SFDA POST-MARKET VIGILANCE (PRIMARY ROLE)1 - Act as the dedicated focal point for SFDA post-market surveillance (PMS) and vigilance activities for all distributed medical devices.2 - Receive, log, triage and investigate customer complaints and reported incidents, coordinating with principals /manufacturers and internal departments.3- Assess reportability of adverse events and submit reports to SFDA through the NCMDR channels within the required timelines, maintaining a complete and auditable vigilance file.Coordinate and execute recalls and Field Safety Corrective Actions (FSCA): distribute Field Safety Notices (FSN), track affected stock, perform quantity reconciliation and effectiveness checks, and prepare closure reports.4- Monitor manufacturer safety communications, FSNs and regulatory alerts, and initiate the corresponding internal actions.5- Maintain complaint and vigilance trending data, and escalate signals and repeated issues to the Quality Manager for CAPA and risk review.6- Support the handling of expired, damaged and non-conforming products in line with internal SOPs and SFDA requirements.7- Prepare periodic vigilance and post-market surveillance reports and maintain records ready for SFDA inspection.B. QUALITY MANAGEMENT SYSTEM SUPPORT (SECONDARY ROLE)1- Support the Quality Manager in maintaining the ISO 13485:2016 QMS, including control of documented information(SOPs, forms, records) under the QA-SOP-XXX framework.2- Assist in raising, tracking and closing CAPAs and nonconformities, and in preparing data for Management Review.3 - Participate in internal and supplier audits as auditor or auditee support, and help follow up audit findings to closure.4 - Support supplier quality tasks, incoming inspection records, and storage / warehouse quality checks (temperature,segregation, traceability).5 - Contribute to customer satisfaction monitoring and internal quality-improvement initiatives.6 - Provide general support to the Quality Manager on quality, compliance and regulatory tasks as assigned.3. QUALIFICATIONS AND EDUCATION REQUIREMENTS:Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, Medical Technology, Nursing, or a relatedscientific / health discipline.Minimum 2 years of experience in quality, regulatory affairs, vigilance within the medical device or healthcare sector.Familiarity with SFDA medical device requirements and with the operation of a QMS.Preferred Certifications & TrainingISO 13485:2016 awareness or internal auditor training (preferred).SFDA vigilance / post-market surveillance training (advantage).Complaint handling, CAPA or root-cause analysis training (advantage).4. Required Knowledge of SFDA Regulations:PMS & Vigilance Post-market surveillance and adverse event reporting requirements, timelines and NCMDR reportingchannels.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 distributeddevices.MDS-G General awareness of relevant SFDA guidance documents and Good Distribution / Storage Practice5. SKILLS AND COMPETENCIES:Strong attention to detail, record-keeping discipline and ability to meet strict reporting deadlines.Good investigation, documentation and communication skills.Proficiency in Arabic and English for SFDA correspondence and reporting.Ability to coordinate across departments (Warehouse, Commercial, Regulatory) and with external principals.Proficiency in MS Office and comfort with electronic reporting portals.Integrity, discretion and a patient-safety mindset.6. Key Working Relationships:Internal Quality Manager, Regulatory Affairs, Warehouse & Logistics, Commercial / Sales, Customer Service.External SFDA / NCMDR, principal manufacturers, Authorized Representatives, customers (hospitals &healthcare providers).