Head of Quality Assurance – Medical Devices | Saudi Arabia

Rawaj-HCM; Riyadh; On-site; SAR 334,800 - 446,400; Full time

Job summary

A prominent medical device manufacturer in Riyadh is seeking a Head of Quality Assurance to oversee all quality operations. The ideal candidate will ensure products meet SFDA and ISO 13485 standards and will have at least 10 years of experience in the medical device sector. Responsibilities include developing the Quality Management System, leading audits, and fostering a culture of quality awareness. Fluency in English is required, with Arabic proficiency preferred.

Qualifications

• Minimum 10+ years of experience in Quality Assurance within the medical device industry.
• Deep understanding of ISO 13485 and GMP standards.

Responsibilities

• Develop and maintain the company’s Quality Management System (QMS).
• Lead internal and external audits and manage CAPA activities.
• Monitor and evaluate quality KPIs and performance metrics.

Skills

Leadership

Analytical skills

Understanding of SFDA requirements

Audit management

Excellent command of English

Arabic proficiency

Education

Bachelor’s degree in Pharmacy, Biomedical Engineering, or Life Sciences

Master’s degree (preferred)

Job description

Leverage your abilities and join a leading company specializing in medical device manufacturing in Saudi Arabia.

The Head of Quality Assurance will lead and oversee all quality operations to ensure products meet the highest standards of safety, performance, and compliance with SFDA and ISO 13485 requirements.

Key Accountabilities

• Develop, implement, and maintain the company’s Quality Management System (QMS) in compliance with SFDA and international standards.

• Lead internal and external audits, manage CAPA activities, and ensure continual improvement.

• Monitor and evaluate quality KPIs and performance metrics across all production lines.

• Oversee process validation, supplier qualification, and document control.

• Collaborate with production and R&D to maintain consistent product quality.

• Promote a strong culture of quality awareness and regulatory compliance across departments.

• Ensure staff training, documentation accuracy, and audit readiness at all times.

Knowledge, Skills, and Experience

• Bachelor’s degree in Pharmacy, Biomedical Engineering, or Life Sciences (Master’s preferred).

• 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 with proven experience in audit management.

• Excellent command of English; Arabic proficiency is an advantage.