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Rawaj HCM JobsPosted 10 months ago

Head of Quality Assurance – Medical Devices | Saudi Arabia

On-siteRiyadh, Riyadh Region, Saudi Arabia

Full TimeSenior Level

Job Summary

Develop and maintain the Quality Management System in compliance with SFDA and ISO 13485 standards. Lead internal and external audits, manage CAPA activities, and monitor quality KPIs across all production lines. Oversee process validation, supplier qualification, and document control while collaborating with production and R&D to ensure consistent product quality. Promote a culture of quality awareness and regulatory compliance, ensuring staff training and audit readiness. Requires a Bachelor's degree in Pharmacy, Biomedical Engineering, or Life Sciences with 10+ years in medical device QA, plus strong leadership skills and English proficiency. Arabic is an advantage.

Required Qualifications

  • Bachelor's degree in Pharmacy, Biomedical Engineering, or Life Sciences
  • Minimum 10+ years of experience in Quality Assurance within the medical device industry
  • Deep understanding of SFDA requirements, ISO 13485, and GMP standards
  • Strong leadership and analytical skills
  • Proven experience in audit management
  • Excellent command of English

Desired Qualifications

  • Master's degree
  • Arabic proficiency

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