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Quality Management Specialist
SDM
Riyadh, KSA
Full Time
Mid
Onsite
1 weeks ago
Quality ManagementISO 13485SFDA RequirementsSoftware as a Medical Device (SaMD)IEC 62304IEC 82304 1
Free
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Quality ManagementISO 13485SFDA Requirements
About the Role
SDM is seeking a Quality Management Specialist to maintain its Quality Management System (QMS) for AI health-tech solutions. The role involves managing SOPs, conducting internal audits, and ensuring compliance with ISO 13485 and SFDA regulations.
Key Skills for This Role
Quality ManagementISO 13485SFDA RequirementsSoftware as a Medical Device (SaMD)IEC 62304IEC 82304 1
Responsibilities
- Maintain and update SOPs and quality documentation
- Conduct internal audits
- Analyze quality data and identify root causes of issues
- Maintain full document control across departments
- Ensure documentation required for SFDA MDMA and MDML is accurate and audit ready
- Track CAPAs through to closure
- Collaborate with cross functional teams to drive continuous improvement
- Prepare quality reports
- Contribute to risk assessments in line with ISO 14971
- Act as point of contact during SFDA inspections and audits
- Support training initiatives related to quality standards and procedures
Requirements
- Strong foundation in Quality Management and Quality Assurance with expert level knowledge of ISO 13485 and SFDA Requirements
- Knowledge of Software as a Medical Device (SaMD) requirements including IEC 62304 and IEC 82304 1
- Hands on experience in Quality Control activities including inspections, testing, internal audits, and documentation
- Experience maintaining SOPs, document control systems, and CAPA management
- Excellent Analytical Skills to interpret data, identify trends, and support root cause analysis
- Effective Communication skills for collaborating with cross functional teams
- Bachelor's degree in Engineering, Quality Management, Healthcare Management, or related field
- Knowledge of quality standards and regulatory requirements relevant to medical devices or healthcare technology (ISO 13485, SFDA MDMA/MDML, SaMD)
- Experience with AI solutions in the medical or healthcare domain is an advantage
- Strong attention to detail, organizational skills, and ability to work independently and within multidisciplinary teams on site
Full Job Posting
Company Description
- SDM is a Health tech startup focusing on diagnosis and detection of chronic diseases using AI to revolutionize healthcare.
Role Description
- Maintain SDM's Quality Management System (QMS), including SOPs and supporting documentation.
- Ensure AI solutions remain compliant with ISO 13485, SaMD requirements, and SFDA regulatory obligations.
- Maintain and update SOPs and quality documentation.
- Conduct internal audits.
- Analyze quality data and identify root causes of issues.
- Maintain full document control across departments.
- Ensure documentation required for SFDA MDMA and MDML is accurate and audit ready.
- Track CAPAs through to closure.
- Collaborate with cross functional teams to drive continuous improvement.
- Prepare quality reports.
- Contribute to risk assessments in line with ISO 14971.
- Act as point of contact during SFDA inspections and audits.
Qualifications
- Strong foundation in Quality Management and Quality Assurance with expert level knowledge of ISO 13485 and SFDA Requirements.
- Knowledge of Software as a Medical Device (SaMD) requirements including IEC 62304 and IEC 82304 1.
- Hands on experience in Quality Control activities including inspections, testing, internal audits, and documentation.
- Experience maintaining SOPs, document control systems, and CAPA management.
- Excellent Analytical Skills to interpret data, identify trends, and support root cause analysis.
- Effective Communication skills for collaborating with cross functional teams.
- Bachelor's degree in Engineering, Quality Management, Healthcare Management, or 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 ability to work independently and within multidisciplinary teams on site.
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