The Quality & Compliance Lead is responsible for establishing, maintaining, and improving Taevas' Quality Management System (ISO 13485) and ensuring compliance with global regulatory standards.

This role ensures that all processes, documentation, and operations meet audit, certification, and regulatory expectations.

Key Responsibilities1. ISO 13485 QMS ImplementationLead end-to-end implementation of ISO 13485.Develop and maintain SOPs, quality manuals, and process documentation.2. Audit & Compliance ManagementPlan and conduct internal audits.Prepare for external audits and certification processes.Address non-conformities through CAPA.3. Quality Systems & ProcessesEstablish CAPA, change control, deviation management, and risk management (ISO 14971).Ensure process standardization across global operations.4. Training & Quality CultureTrain teams on QMS requirements and compliance processes.Preferred Profile6-12+ years in QMS / Quality AssuranceHands-on experience in ISO 13485 implementationExperience handling external auditsBackground in medical device manufacturing preferredStrong process and documentation mindset

📌 Manager & Quality Compliance (ISO 13485) (Secunderabad)
🏢 Taevas Life Sciences
📍 Secunderabad