Quality Assurance Specialist
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Key skills for this role
About the Role
Saudi Mais For Medical Products Co. is hiring a Quality Assurance Specialist to maintain and improve the Quality Management System for medical device manufacturing. The role requires 2-5 years of QA experience in medical devices or pharmaceuticals and knowledge of ISO 13485, SFDA, FDA, and EU MDR regulations.
Key Skills for This Role
Responsibilities
- Establish, maintain, and improve 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
Requirements
- 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
Full Job Posting
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
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