Quality Control Manager – Medical Devices

About the role

We are seeking an experienced Quality Control Manager to lead the QC function for our medical device and supplies manufacturing site in Nasr City, Cairo. The role oversees laboratory operations, ensures product compliance, and drives continuous improvement across the quality system.

Key responsibilities

• Manage and supervise all Quality Control activities, laboratory operations and QC personnel.
• Ensure raw materials, packaging, in‑process and finished products meet approved specifications and regulatory requirements.
• Develop, review and implement QC procedures, specifications, testing methods, inspection plans and SOPs.
• Review laboratory test results and inspection reports, guaranteeing accuracy and reliability of QC records.
• Supervise physical, chemical and microbiological testing, and maintain calibration and qualification of laboratory equipment.
• Investigate Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) results and lead CAPA activities.
• Participate in internal, supplier, customer and regulatory audits, ensuring compliance with ISO 13485, GMP and GLP.
• Monitor quality trends, rejection rates and KPIs, and coordinate with cross‑functional teams to resolve issues.
• Lead, train, coach and evaluate the Quality Control team and prepare periodic QC reports.

Required profile

• Bachelor’s degree in Science, Chemistry, Pharmacy, Engineering or related discipline.
• Minimum 8 years of QC experience in medical device, medical supplies or pharmaceutical manufacturing.
• At least 3 years in a supervisory or managerial position.
• Strong knowledge of ISO 13485, GMP, GLP, CAPA, OOS, OOT, root‑cause analysis and risk management.
• Excellent English communication and ability to work under pressure.

Required skills

• ISO 13485
• GMP
• GLP
• CAPA
• Out‑of‑Specification (OOS) handling
• Out‑of‑Trend (OOT) analysis
• Root‑cause analysis
• Risk management
• Laboratory equipment calibration and qualification
• Microsoft Office applications