Quality Assurance Manager

Overview

Leadership role responsible for following and managing the Quality Management System (QMS) and quality function at the Sri City manufacturing site. The Quality Manager ensures all products and processes meet ISO 13485, regulatory, and customer requirements, and builds a strong culture of quality across the site. Ideal for an experienced quality professional with hands-on QMS experience in a regulated medical device manufacturing environment.

Key Responsibilities

Quality Management System

• Follow the site QMS in compliance with ISO 13485 and applicable regulatory requirements.
• Live the quality policies, procedures, and document control system.
• Lead management reviews, internal audits, and continuous improvement of the QMS.

Regulatory & Customer Compliance

• Ensure site compliance with applicable medical device regulations and customer-specific requirements.
• Host and manage external audits by notified bodies, regulators, and customers.
• Maintain technical documentation and support regulatory submissions as required.

Quality Assurance & Control

• Oversee incoming, in-process, and final inspection activities.
• Manage non-conformance, deviation, complaint, and CAPA processes.
• Ensure robust batch record review and product release processes.

Supplier & Process Quality

• Oversee supplier qualification, supplier audits, and supplier quality performance with the supply chain function.
• Drive process validation, risk management (ISO 14971), and design transfer activities.
• Lead root cause analysis and structured problem solving for quality issues.

Team & Culture

• Lead and develop the quality team including inspectors and supplier quality staff.
• Build a proactive, accountable culture of quality across all departments.
• Deliver quality training and promote awareness of GMP and regulatory expectations.

Core Competencies

Personal

• High integrity; uncompromising on product safety and compliance.
• Calm and structured under audit and escalation pressure.

Leadership

• Credible with shop-floor teams, senior management, and external auditors alike.
• Skilled at influencing cross-functional teams to own quality outcomes.
• Clear communicator in audits, investigations, and regulatory interactions.

Technical

• Knowledge of ISO 13485 and medical device QMS requirements.
• Experience with CAPA, non-conformance, complaint handling, and audit management.
• Strong grounding in risk management (ISO 14971) and process validation (IQ/OQ/PQ).
• Familiarity with statistical methods, SPC, and structured problem-solving tools.

Qualifications

• Degree in Engineering, Science, or a related technical field.
• 10+ years in quality roles in medical device or regulated manufacturing, with at least 3 years in a leadership position.
• Lead Auditor certification (ISO 13485) preferred.
• Professional proficiency in English required.
• Proficiency in Telugu and/or Tamil required.