Quality Assurance Specialist

🔬 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, andlocally manufactured solutions that support the Kingdom’s healthcare sector and Vision 2030.Role OverviewAs 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