Quality Assurance Manager

dVise Medtech Private Limited; Tirupati; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

dvise Medtech Private Limited is seeking an experienced Quality Manager for its Sri City, Andhra Pradesh manufacturing site. You will own the Quality Management System and ensure ISO 13485 compliance across products and processes.

You will lead audits, drive CAPA, and build a strong quality culture with shop-floor teams and auditors, while developing the quality organization and ensuring regulatory and customer requirements are met.

Qualifications

• Degree in Engineering, Science, or a related technical field.
• 8-10+ years in quality roles in medical device or regulated manufacturing; minimum 3 years in leadership.
• Strong knowledge of ISO 13485 and medical device QMS requirements.
• Hands-on experience with CAPA, non-conformance, complaint handling, and audit management.

Responsibilities

• Maintain and improve the site QMS in compliance with ISO 13485 and 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.

Skills

Quality management

GMP

Audit management

CAPA

Risk management

Education

Engineering or Science degree

Tools

Lead Auditor certification (ISO 13485)

Job description

Quality Manager

Location: Sri City, Andhra Pradesh | On-site | 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
• Strong 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