Quality Assurance Specialist

🔬 We're Hiring: Quality Assurance Specialist |

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.

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.

✅ 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