Quality Assurance Manager

Company Details: Our client is a Leading Medical Pharma Company

Designation: Quality Assurance Manager

Job Location: Sanand GIDC, Gujarat, India

Role Overview

We are looking for an experienced Quality Assurance Manager to lead and strengthen our Quality Management System (QMS) for medical devices. The ideal candidate will ensure compliance with ISO 13485, EU MDR, FDA QSR/QMSR, and other applicable regulatory requirements while driving quality excellence across manufacturing operations.

Key Responsibilities

• Lead and maintain the Quality Management System (QMS) in compliance with ISO 13485, EU MDR, FDA QSR/QMSR, and other applicable regulations.
• Manage quality documentation, SOPs, document control, change control, and QMS performance metrics.
• Plan, conduct, and coordinate internal, supplier, certification, and regulatory audits, ensuring timely CAPA closure.
• Drive CAPA, Non-Conformance (NCR), deviation management, root cause analysis, and continuous improvement initiatives.
• Oversee risk management activities throughout the product lifecycle in line with ISO 14971.
• Review and approve validation activities including Process, Equipment (IQ/OQ/PQ), Packaging, Sterilization, Cleaning, Test Method, and Software Validation.
• Ensure supplier qualification, supplier audits, performance monitoring, and supplier quality improvements.
• Manage complaint handling, post-market surveillance, vigilance support, and product quality trend analysis.
• Review Device History Records (DHR) and authorize product/batch release ensuring regulatory compliance.
• Conduct QMS and regulatory training while promoting a strong quality culture across the organization.
• Support implementation and continuous improvement of electronic Quality Management Systems (eQMS) and digital quality initiatives.
• Participate in management reviews and provide strategic quality leadership across cross-functional teams.

Key Requirements

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related discipline.
• Minimum 10 years of experience in the Medical Device Industry, including at least 5 years in a Quality Assurance leadership role.
• Hands-on experience with ISO 13485 implementation, EU MDR compliance, validation activities, audits, CAPA, complaint handling, supplier quality, and risk management.
• Strong knowledge of ISO 13485, EU MDR 2017/745, ISO 14971, ISO 11135, ISO 11137, ISO 11607, Design Controls, GMP, Validation, CAPA, Statistical Tools, and Document Control.
• Internal Auditor Certification (ISO 13485) will be an added advantage.
• Excellent leadership, communication, analytical, project management, and decision-making skills with a continuous improvement mindset.

Contact Person:

Ansuya Satish

[email protected]