QMS Engineer

Job Description

Develop, implement, and maintain the Quality Management System (QMS) according to ISO 13485 and SFDA requirements.

Prepare and control SOPs, forms, and quality documentation for all departments.

Conduct internal audits and coordinate external audits (ISO / SFDA).

Ensure compliance with ISO 11135 (EO sterilization) documentation and validation requirements.

Work closely with Production, QC, and R&D to ensure process quality and continual improvement.

Manage CAPA (Corrective and Preventive Actions), Change Control, and Non-Conformance reports.

Maintain training records, calibration logs, and document revision control.

Support management reviews and quality objectives tracking.

Desired Candidate Profile

Indian, Pakistani

Master of Technology/Engineering(Any, Production/Industrial)

Male

Bachelor’s degree in Engineering, Biomedical, or Quality Management (or equivalent). 3–7 years of experience in medical device or plastic consumable manufacturing. Strong understanding of ISO 13485:2016 and awareness of ISO 11135 / CE / SFDA guidelines. Experience in cleanroom environments (ISO 7/8) preferred. Skilled in documentation, internal audit, CAPA, and process validation. Good communication skills in English (written and spoken). Ready to relocate to Saudi Arabia (visa and accommodation provided).