Job Type: Full-time

Quality ManagerLocation: Sri City, Andhra Pradesh | On-site | Full time | Starts November 2026About the roleWe are looking for an experienced quality leader to own the Quality Management System and quality function at our Sri City manufacturing site. The Quality Manager ensures all products and processes meet ISO 13485, regulatory, and customer requirements — and builds a proactive, accountable culture of quality across the site.The right person is uncompromising on product safety and compliance, credible with shop-floor teams and external auditors alike, and effective at driving quality ownership across functions.Key responsibilitiesMaintain and continuously improve the site QMS in compliance with ISO 13485 and applicable regulatory requirementsLead management reviews, internal audits, and document controlHost and manage external audits by notified bodies, regulators, and customersOversee incoming, in-process, and final inspection activities, including batch record review and product releaseManage non-conformance,



deviation, complaint, and CAPA processesDrive process validation, risk management (ISO 14971), and design transfer activitiesOversee supplier qualification, supplier audits, and supplier quality performanceLead and develop the quality team; deliver GMP and quality training across the siteWhat we're looking forDegree in Engineering, Science, or a related technical field8–10+ years in quality roles in medical device or regulated manufacturing, with at least 3 years in a leadership positionStrong knowledge of ISO 13485 and medical device QMS requirementsHands-on experience with CAPA, non-conformance, complaint handling, and audit managementGrounding in risk management (ISO 14971), process validation (IQ/OQ/PQ), and structured problem-solvingLead Auditor certification (ISO 13485) preferredProficiency in Telugu and/or Tamil required

📌 Quality Assurance Manager (India)
🏢 dVise Medtech Private
📍 India