Quality Assurance Medical Devices, Section Head

Main Purpose of Job

Establish and maintain control over the QMS and BCM to ensure that all medical devices distribution, storage, and logistics operations comply with Saudi regulatory authorities, SFDA requirements, and international standards.

Functional Responsibilities

• Establish, maintain, and continually improve the Quality Management System (QMS) and Business Continuity Management (BCM) to ensure full compliance with SFDA and international standards (e.g., ISO 13485, 9001, 45001, 22301).

• Develop and control quality-related policies, SOPs, and procedures across all operations (procurement, warehousing, sales, and distribution).

• Ensure regulatory compliance of all facilities and logistics operations with SFDA and relevant authorities.

• Lead external audits (SFDA, licensors) and manage internal audit programs, ensuring timely CAPA implementation.

• Oversee risk management (QRM) and business continuity (BCP/BCM) processes for all distribution activities.

• Monitor quality KPIs and drive continuous improvement initiatives to enhance operational excellence.

• Supervise warehouse quality operations, ensuring adherence to Good Storage Practices (GSP), environmental control, and proper product disposition.

• Manage training programs on GMP/GDP/GSP and ensure technical competency of sales, logistics, and clinical teams.

• Handle customer complaints, post-market surveillance, and regulatory reporting (MDR/adverse events) to SFDA.

• Oversee supplier qualification and audits to ensure compliance with medical device quality standards.

• Support ESG and HSE initiatives, ensuring safe waste management and sustainability compliance.

Job Requirements

Qualifications

• Bachelor’s degree in Engineering, Science or Regulatory Affairs.

Experience

• Minimum 3 years in related field of Operations

Language

• Required English - proficient.
• Preferred Arabic - proficient.