Overview
Quality Assurance Specialist Jobs in Riyadh, Riyadh, Saudi Arabia at Saudi Mais For Medical Products Co.
Title: Quality Assurance Specialist
Company: Saudi Mais For Medical Products Co.
Location: Riyadh, Riyadh, Saudi Arabia
🔬 We're Hiring: Quality Assurance Specialist | Saudi Nationals Only
About us:
Established in 1994, Saudi Mais is a Saudi manufacturer of high-quality single-use medical devices.
We are dedicated to advancing healthcare through innovation, international quality standards, and
locally manufactured solutions that support the Kingdom’s healthcare sector and Vision 2030.
Role Overview
As a QA Specialist, you will play a key role in maintaining and improving our Quality Management System,
ensuring full compliance with ISO 13485, SFDA, FDA 21 CFR 820, EU MDR, and other applicable regulations.
Key Responsibilities:
✅ Establish, maintain, and improve our QMS in line with ISO 13485, SFDA, FDA, and EU MDR requirements
✅ Initiate, track, and close CAPAs and manage non-conformance reports (NCRs)
✅ Conduct internal audits and support regulatory inspections and supplier audits
✅ Review and maintain SOPs, device master records, and manufacturing records
✅ Oversee risk management activities per ISO 14971
✅ Investigate customer complaints and identify root causes
✅ Review and perform line-by-line batch record reviews for accuracy and completeness
✅ Maintain document control systems (DHRs, DMRs, DHFs) with full integrity
✅ Coordinate with SFDA, ISO Registrars, and customers during audits
🎓 Qualifications:
🔹 Degree in Life Sciences, Pharmacy, Engineering, or a related field
🔹 2–5 years of QA experience in medical devices, pharmaceuticals, or a related industry
🔹 Strong knowledge of ISO 13485, SFDA, FDA 21 CFR 820 & Part 11, EU MDR
🔹 Proficiency in root cause analysis, risk assessment, and technical writing
🔹 ISO 13485 Auditor / Lead Auditor certification is a plus
📍 Location: Saudi Arabia, Riyadh
Job Type: Full Time
