Quality Management Specialist

About SDM

SDM is a pioneering Health-tech startup dedicated to revolutionizing the healthcare industry through the diagnosis and detection of chronic diseases. By leveraging cutting-edge artificial intelligence, we are transforming healthcare into a more efficient, sustainable, and accessible system for all. Our mission is to bridge the gap between technology and medicine, ensuring that high-quality diagnostic solutions are within reach for every individual.

Role Overview

We are seeking a highly motivated and detail-oriented Quality Management Specialist to join our team in Riyadh. This full-time, on-site position plays a critical role in maintaining and enhancing SDM’s Quality Management System (QMS), ensuring that our AI-powered medical solutions adhere to the highest standards of quality, compliance, and regulatory excellence. The successful candidate will be responsible for upholding and improving our documentation, audit processes, and quality assurance protocols to meet ISO 13485, Software as a Medical Device (SaMD) requirements, and the stringent regulatory obligations set forth by the Saudi Food & Drug Authority (SFDA).

Key Responsibilities

The Quality Management Specialist will oversee a wide range of responsibilities to ensure the integrity and compliance of our quality systems, including:

• Quality Documentation Management: Maintain, update, and ensure the accuracy of Standard Operating Procedures (SOPs) and supporting quality documentation across all departments. Implement and enforce robust document control systems to guarantee consistency and audit readiness.
• Internal Audits & Compliance: Conduct thorough internal audits to assess adherence to quality standards, regulatory requirements, and internal policies. Identify gaps, document findings, and recommend corrective actions to mitigate risks and ensure continuous improvement.
• Regulatory & SFDA Compliance: Ensure all documentation and processes align with SFDA Medical Device Marketing Authorization (MDMA) and Medical Device Marketing License (MDML) requirements. Act as a primary point of contact during SFDA inspections and audits, providing clear and concise responses to regulatory inquiries.
• CAPA Management: Lead and track Corrective and Preventive Actions (CAPAs) from identification to closure, ensuring timely resolution and verification of effectiveness. Analyze quality data to identify trends and root causes of non-conformities, driving proactive improvements.
• Cross-Functional Collaboration: Work closely with product development, regulatory affairs, operations, and other teams to integrate quality principles into all stages of the product lifecycle. Facilitate training initiatives to ensure employees are well-versed in quality standards and procedures.
• Risk Assessment & Reporting: Contribute to risk assessments in accordance with ISO 14971, supporting the identification and mitigation of potential hazards associated with our AI solutions. Prepare comprehensive quality reports for internal stakeholders and regulatory bodies as required.

Qualifications & Skills

To excel in this role, candidates must possess the following qualifications and competencies:

• Expertise in Quality Management: A strong foundation in Quality Management and Quality Assurance, with in-depth knowledge of ISO 13485 and the documentation required to maintain SFDA compliance.
• Regulatory Knowledge: Familiarity with Software as a Medical Device (SaMD) requirements, including IEC 62304 (software lifecycle) and IEC 82304-1. Understanding of medical device regulations and standards relevant to the healthcare technology sector is essential.
• Quality Control Experience: Hands-on experience in quality control activities, such as inspections, testing, internal audits, and the documentation of quality results. Proven ability to maintain SOPs, document control systems, and CAPA management processes.
• Analytical & Problem-Solving Skills: Exceptional analytical abilities to interpret complex data, identify trends, and support root cause analysis. A proactive approach to continuous improvement and risk mitigation is highly valued.
• Communication & Collaboration: Excellent written and verbal communication skills to effectively collaborate with cross-functional teams, document processes, and present quality findings to stakeholders at all levels.
• Educational Background: A Bachelor’s degree in Engineering, Quality Management, Healthcare Management, or a related field. Additional certifications in quality management or regulatory affairs are a plus.
• Industry Experience: Prior experience in quality assurance or regulatory compliance within the medical device or healthcare technology industry is required. Knowledge of AI solutions in the medical or healthcare domain is considered an advantage.
• Personal Attributes: Meticulous attention to detail, exceptional organizational skills, and the ability to work independently as well as within multidisciplinary teams. A commitment to maintaining the highest standards of quality and compliance is essential.

If you are a dedicated professional with a passion for quality and regulatory excellence, we invite you to apply and become a key contributor to SDM’s mission of transforming healthcare through innovation.