Quality Management Specialist

Company Description

SDM is a Health-tech startup that focuses on diagnosis and detection of chronic diseases by harnessing the power of artificial intelligence to revolutionize the healthcare industry and transforming it into an efficient and sustainable system accessible to all.

Role Description

The Quality Management Specialist is a full-time, on-site role based in Riyadh. This position is responsible for maintaining SDM's Quality Management System (QMS), including its SOPs and supporting documentation, to ensure our AI solutions remain compliant with ISO 13485, Software as a Medical Device (SaMD) requirements, and the regulatory obligations of SFDA . Day-to-day tasks include maintaining and updating SOPs and quality documentation, conducting internal audits, analyzing quality data, and identifying root causes of issues. The specialist maintains full document control across departments, ensures all documentation required to sustain our SFDA MDMA and MDML is accurate and audit-ready, and tracks CAPAs through to closure. This role collaborates closely with cross-functional teams (such as product development, regulatory, and operations) to drive continuous improvement, document findings, and support corrective and preventive actions. The role also involves preparing quality reports, contributing to risk assessments in line with ISO 14971, acting as a point of contact during SFDA inspections and audits, and supporting training initiatives related to quality standards and procedures.

Qualifications

• Strong foundation in Quality Management and Quality Assurance, with expert-level knowledge of ISO 13485 and the documentation required to maintain SFDA Requirements
• Knowledge of Software as a Medical Device (SaMD) requirements, including IEC 62304 (software lifecycle) and IEC 82304-1
• Hands-on experience in Quality Control activities, including inspections, testing, internal audits, and documentation of quality results
• Experience maintaining SOPs, document control systems, and CAPA management
• Excellent Analytical Skills to interpret data, identify trends, and support root cause analysis and continuous improvement
• Effective Communication skills for collaborating with cross-functional teams, documenting processes, and presenting quality findings
• Bachelor's degree in Engineering, Quality Management, Healthcare Management, or a related field
• Knowledge of quality standards and regulatory requirements relevant to medical devices or healthcare technology (ISO 13485, SFDA MDMA/MDML, SaMD) is required
• Experience with AI solutions in the medical or healthcare domain is an advantage
• Strong attention to detail, organizational skills, and the ability to work independently and within multidisciplinary teams on-site