Job Description

Description

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

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

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Key Responsibilities

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ISO 13485 QMS Implementation

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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).
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Audit & Compliance Management

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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

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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.
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Training & Quality Culture

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Train teams on QMS requirements and compliance processes.
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Drive organization-wide quality awareness.
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Preferred Profile

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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