Company Details: Our client is a Leading Pharma Manufacturer
Designation: Quality Assurance Manager
Job Location: Sanand, Ahmedabad
Role Overview:-
We are looking for a person to lead and strengthen its Quality Management System (QMS). The role is responsible for ensuring compliance with ISO 13485, EU MDR, FDA QSR, and other regulatory standards while driving continuous quality improvement across the organization.
Key Responsibilities
- Lead and maintain the Quality Management System (QMS) in line with ISO 13485, EU MDR, FDA QSR, and applicable regulatory requirements.
- Manage quality documentation, SOPs, document control, change control, and Management Review activities.
- Plan and conduct internal audits while coordinating external, supplier, and regulatory audits.
- Lead CAPA, non-conformance, deviation, complaint investigations, and root cause analysis.
- Oversee risk management activities throughout the product lifecycle.
- Review and approve validation activities, including process, equipment, packaging, sterilization, cleaning, software, and test method validations.




- Manage supplier quality activities, including supplier qualification, audits, and corrective actions.
- Ensure effective complaint handling, post-market surveillance, and regulatory compliance.
- Review Device History Records (DHR) and authorize product release while monitoring product quality trends.
- Conduct QMS and regulatory training programs to promote a strong quality culture.
- Support implementation and continuous improvement of electronic Quality Management Systems (eQMS) and digital quality initiatives.
- Drive continuous improvement initiatives while ensuring regulatory readiness across all departments.

Key Requirements
- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field.
- Minimum 10 years of experience in the medical device industry, including 5+ years in a Quality Assurance leadership role.
- Robust expert

📌 Quality Assurance Manager (Ahmedabad)
🏢 United HR solution
📍 Ahmedabad