Job Description Description
n The Quality & Compliance Lead is responsible for establishing, maintaining, and improving Taevas' Quality Management System (ISO 13485) and ensuring compliance with global regulatory standards.
n This role ensures that all processes, documentation, and operations meet audit, certification, and regulatory expectations.
n Key Responsibilities
n 1. ISO 13485 QMS Implementation
n n Lead end-to-end implementation of ISO 13485.
n Develop and maintain SOPs, quality manuals, and process documentation.
n Ensure alignment across departments (Regulatory, Supply Chain, Service Delivery).
n n 2. Audit & Compliance Management
n n Plan and conduct internal audits.
n Prepare for external audits and certification processes.
n Address non-conformities through CAPA.
n n 3. Quality Systems & Processes




n n Establish CAPA, change control, deviation management, and risk management (ISO 14971).
n Maintain documentation control systems.
n Ensure process standardization across global operations.
n n 4. Training & Quality Culture
n n Train teams on QMS requirements and compliance processes.
n Drive organization-wide quality awareness.
n n Preferred Profile
n n 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 Robust process and documentation mindset
n

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