Head Quality Assurance

Role & responsibilities

• Lead implementation and continuous improvement of ISO 13485-compliant QMS.
• Ensure compliance with FDA QSR (21 CFR 820), EU MDR, and other applicable regulatory requirements.
• Manage internal and external audits (FDA, notified bodies, ISO, etc.).
• Oversee document control, change control, and quality records management.
• Approve quality documentation, SOPs, DMRs, DHFs, and technical files.
• Lead root cause investigations and implement effective corrective and preventive actions.
• Manage nonconformances and track resolution effectiveness.
• Approve and audit suppliers and subcontractors.
• Ensure incoming materials and components meet specifications.
• Collaborate with production and engineering to ensure process validations (IQ/OQ/PQ) are performed and documented.
• Ensure in-process and final product testing meets quality standards.
• Prepare for and host regulatory inspections and third-party audits.
• Maintain inspection readiness at all times.
• Manage and mentor the QA team.
• Ensure ongoing quality and compliance training for all relevant staff.
• Support risk management (ISO 14971) and post-market surveillance activities. Review complaints and adverse event reports to ensure timely investigation and resolution

Preferred candidate profile

• Leadership and team management
• Attention to detail and analytical thinking
• Excellent communication and documentation skills
• Strong problem-solving and decision-making abilities
• Project management and cross-functional collaboration