Quality Assurance Lead

Nhara Healthcare Industries; Saudi Arabia; On-site; SAR 120,000 - 150,000; Full time

Job summary

A Saudi-based healthcare company is seeking a Quality Assurance Lead to ensure compliance with industry standards and manage quality systems. The role requires extensive experience in quality assurance within the medical device sector, focusing on regulatory compliance and documentation. Join a dynamic team dedicated to improving healthcare outcomes through innovation.

Benefits

Competitive salary and attractive commission structure

Career growth and continuous learning opportunities

Supportive work culture

Qualifications

• 13 years of Quality Assurance experience in the medical device industry.
• Hands-on experience with ISO 13485, FDA, and EU MDR compliance.

Responsibilities

• Maintain ISO 13485-compliant QMS.
• Support internal audits and external inspections.
• Prepare Quality KPIs and audit readiness reports.

Skills

Attention to Detail

Cross-Functional Communication

Education

Bachelor's degree in engineering

Biomedical Engineering

Life Sciences

Job description

About Nhara:

Nhara Healthcare Industries is a Saudi-based company dedicated to manufacturing and distributing high-quality, locally made medical solutions. We specialize in wound care and surgical consumables, committed to empowering healthcare professionals and elevating patient outcomes through innovation, education, and partnership. At Nhara, we believe in a future where healthcare is advanced by local excellence.

We are seeking a talented, detail-oriented, and driven Saudi-based Quality Assurance Lead to join our ambitious team immediately at our headquarters in Riyadh, Saudi Arabia.

Key Responsibilities:

• Maintain ISO 13485-compliant QMS.
• Ensure compliance with FDA QSR (21 CFR Part 820), EU MDR & SFDA.
• Manage document control and change control.
• Support internal audits and external inspections.
• Assist with CAPA, non-conformances, and root cause analysis.
• Participate in risk management (ISO 14971).
• Support training and compliance tracking.
• Prepare Quality KPIs and audit readiness reports.
• Maintain DHF, DMR, and other quality records.

Qualifications and Requirements:

• Bachelor's degree in engineering, Biomedical Engineering, Life Sciences, or related technical discipline.
• 13 years of Quality Assurance experience in the medical device industry, with demonstrated leadership or coordination responsibilities.
• Saudi Nationals (preferred).
• Hands-on experience working in compliance with ISO 13485, SFDA,FDA 21 CFR Part 820, and EU MDR (preferably).
• Understanding of Design Controls, Risk Management (ISO 14971), and Quality Management Systems (QMS).
• Exposure to internal audits, CAPA, NCRs, and Document Control systems.
• Strong attention to detail with excellentdocumentation and report writingskills.
• Effectivecross-functional communication(R&D, Regulatory, Manufacturing).

Why Join Nhara

• Competitive salary and attractive commission structure.
• Career growth and continuous learning opportunities.
• A dynamic, forward-thinking, and supportive work culture where your contributions matter.

Ready to make an impact

Apply now and be part of shaping the future of Healthcare, and follow us for more upcoming opportunities @NharaHC