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 /n Key Responsibilities /n 1. ISO 13485 QMS Implementation /n /n
Lead end-to-end implementation of ISO 13485.

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Develop and maintain SOPs, quality manuals, and process documentation.

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Ensure alignment across departments (Regulatory, Supply Chain, Service Delivery).

/n /n 2. Audit & Compliance Management /n /n
Plan and conduct internal audits.

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Prepare for external audits and certification processes.

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Address non-conformities through CAPA.

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Quality

Systems & Processes /n /n




Establish CAPA, change control, deviation management, and risk management (ISO 14971).

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Maintain documentation control systems.

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Ensure process standardization across global operations.

/n /n 4. Training & Quality Culture /n /n
Train teams on QMS requirements and compliance processes.

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Drive organization-wide quality awareness.

/n /n Preferred Profile /n /n
6–12+ years in QMS / Quality Assurance

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Hands-on experience in ISO 13485 implementation

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Experience handling external audits

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Background in medical device manufacturing preferred

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Robust process and documentation mindset

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📌 Manager Quality & Compliance Iso 13485 Hyderabad
🏢 Taevas Life Sciences
📍 Hyderabad