Quality Management Specialist

About the role

The Quality Management Specialist will join SDM’s Riyadh office to oversee and continuously improve the company’s Quality Management System (QMS) for its AI‑driven medical solutions. You will ensure compliance with ISO 13485, SaMD regulations and Saudi FDA (SFDA) requirements while supporting product development and operations.

Key responsibilities

• Maintain and update SOPs, quality documentation and the document‑control system across all departments.
• Conduct internal audits, analyse quality data and perform root‑cause investigations.
• Track corrective and preventive actions (CAPAs) to closure and ensure audit‑ready records for SFDA MDMA/MDML.
• Collaborate with product development, regulatory and operations teams to drive continuous improvement.
• Prepare quality reports and contribute to risk assessments in line with ISO 14971.
• Act as the primary contact during SFDA inspections and audits.
• Support training initiatives on quality standards and procedures.

Required profile

• Strong foundation in Quality Management and Assurance with expert knowledge of ISO 13485 and SFDA documentation requirements.
• Understanding of SaMD regulations, including IEC 62304 and IEC 82304‑1.
• Hands‑on experience in quality‑control activities such as inspections, testing, internal audits and documentation.
• Proven ability to maintain SOPs, document‑control systems and CAPA management.
• Bachelor’s degree in Engineering, Quality Management, Healthcare Management or a related field.
• Excellent analytical and communication skills, attention to detail and ability to work independently and in multidisciplinary teams.
• Experience with AI solutions in the medical or healthcare domain is a plus.

Required skills

• ISO 13485
• IEC 62304
• IEC 82304‑1
• ISO 14971
• SFDA MDMA / MDML compliance
• SaMD regulatory knowledge
• CAPA management
• Document‑control systems