Job DescriptionDescription NThe Quality & Compliance Lead is responsible for establishing, maintaining, and improving Taevas' Quality Management System (ISO 13485) and ensuring compliance with global regulatory standards. NThis role ensures that all processes, documentation, and operations meet audit, certification, and regulatory expectations. NKey Responsibilitiesn1. ISO 13485 QMS Implementation Nn Lead end-to-end implementation of ISO 13485. N Develop and maintain SOPs, quality manuals, and process documentation. N Ensure alignment acrossdepartments (Regulatory, Supply Chain, Service Delivery). Nn2. Audit & Compliance Management Nn Plan and conduct internal audits. N Prepare for external audits and certification processes. N Address non-conformities through CAPA. Nn3.
Quality Systems& Processes Nn Establish CAPA, change control, deviation management, and risk management (ISO 14971). N Maintain documentation control systems. N Ensure process standardization across global operations. Nn4. Training & Quality Culture Nn Train teams on QMS requirements and compliance processes. N Drive organization-widequality awareness. NnPreferred Profile Nn 6–12+ years in QMS / Quality Assurance N Hands-on experience in ISO 13485 implementation N Experience handling external audits N Background in medical device manufacturing preferred N Solid process and documentation mindset N