QMS Engineer

Responsibilities:

• Develop and maintain Quality Management System in compliance with International Organization for Standardization standards (ISO 9001 and ISO 13485).

• Plan and coordinate Internal and External Audits.

• Analyze audit results and monitor Corrective & Preventive Actions (CAPA).

• Organize QMS training and ensure employee awareness.

• Conduct legal and regulatory compliance assessments.

• Prepare KPI reports and Management Review reports.

Qualifications:

• Bachelor’s degree in a related field.

• Experience in ISO 9001 and/or ISO 13485 systems.

• Knowledge of Internal Audit and CAPA processes.

• Strong analytical, coordination, and reporting skills.