Quality Manager

Location: Sri City, Andhra Pradesh | In office | Full time | Starts November 2026

About the role

We 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 responsibilities
Maintain and continuously improve the site QMS in compliance with ISO 13485 and applicable regulatory requirements
Lead management reviews, internal audits, and document control
Host and manage external audits by notified bodies, regulators, and customers
Oversee incoming, in-process, and final inspection activities, including batch record review and product release
Manage non-conformance,



deviation, complaint, and CAPA processes
Drive process validation, risk management (ISO 14971), and design transfer activities
Oversee supplier qualification, supplier audits, and supplier quality performance
Lead and develop the quality team; deliver GMP and quality training across the site

What we're looking for
Degree in Engineering, Science, or a related technical field
8–10+ years in quality roles in medical device or regulated manufacturing, with at least 3 years in a leadership position
Solid knowledge of ISO 13485 and medical device QMS requirements
Hands-on experience with CAPA, non-conformance, complaint handling, and audit management
Grounding in risk management (ISO 14971), process validation (IQ/OQ/PQ), and structured problem-solving
Lead Auditor certification (ISO 13485) preferred
Proficiency in Telugu and/or Tamil required

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