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 Responsibilities
n1. ISO 13485 QMS Implementation
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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

n2. Audit & Compliance Management
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Plan and conduct internal audits.n
Prepare for external audits and certification processes.n
Address non-conformities through CAPA.n

n3. Quality Systems & Processes
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Establish CAPA, change control, deviation management, and risk management (ISO 14971).n
Maintain documentation control systems.n
Ensure process standardization across global operations.n

n4. Training & Quality Culture
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Train teams on QMS requirements and compliance processes.n
Drive organization-wide quality awareness.n

nPreferred Profile
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6–12+ years in QMS / Quality Assurancen
Hands-on experience in ISO 13485 implementationn
Experience handling external auditsn
Background in medical device manufacturing preferredn
Robust process and documentation mindsetn

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