Head of Quality Assurance – Medical Devices | Saudi Arabia

RAWAJ; Riyadh; On-site; SAR 200,000 - 300,000; Full time

Job summary

A leading medical device manufacturer in Saudi Arabia is seeking a Head of Quality Assurance to oversee quality operations and ensure compliance with SFDA and ISO 13485 standards. The ideal candidate will have extensive experience in quality assurance within the medical device industry, strong leadership skills, and the ability to promote a culture of quality across departments. This role is vital for maintaining the highest product standards.

Qualifications

• 10+ years of experience in Quality Assurance within the medical device industry.
• Deep understanding of SFDA requirements, ISO 13485, and GMP standards.
• Excellent command of English; Arabic proficiency is an advantage.

Responsibilities

• Develop and maintain the Quality Management System (QMS).
• Lead internal and external audits and manage CAPA activities.
• Monitor and evaluate quality KPIs and performance metrics.
• Oversee process validation, supplier qualification, and document control.
• Promote a culture of quality awareness and regulatory compliance.

Skills

Leadership

Analytical skills

Quality management

Audit management

Regulatory compliance

Education

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

Job description

Overview

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.