Head Of Quality Assurance

Company Description

S3V Vascular Technologies is dedicated to becoming a global leader in medical technology, focusing on improving the lives of patients with cardiovascular diseases. By leveraging deep expertise and strong collaborations with physicians worldwide, we develop innovative medical devices and therapies to revolutionize cardiovascular care. Managed by a team of experienced professionals, S3V Vascular integrates global best practices in device development, physician education, and patient awareness. With ambitious goals and multiple strategic initiatives, the company is on a mission to become a market leader in its key focus areas.

Role Description:

This full-time, on-site role of Head of Quality Assurance is based in Chennai. The individual will oversee quality assurance strategies, ensure adherence to quality management systems, and lead quality auditing and control processes. Responsibilities include managing compliance to regulatory standards, implementing quality improvement initiatives, and coordinating cross-functional quality processes to maintain high standards of medical technology development.

Key Responsibilities:

Lead implementation and continuous improvement of ISO 13485-compliant QMS. Ensure compliance with FDA QSR (21 CFR 820), EU MDR, and other applicable regulatory requirements. Manage internal and external audits (FDA, notified bodies, ISO, etc.). Oversee document control, change control, and quality records management. Approve quality documentation, SOPs, DMRs, DHFs, and technical files. Lead root cause investigations and implement effective corrective and preventive actions. Manage nonconformances and track resolution effectiveness. Approve and audit suppliers and subcontractors. Ensure incoming materials and components meet specifications. Collaborate with production and engineering to ensure process validations (IQ/OQ/PQ) are performed and documented. Ensure in-process and final product testing meets quality standards. Prepare for and host regulatory inspections and third-party audits. Maintain inspection readiness at all times. Manage and mentor the QA team. Ensure ongoing quality and compliance training for all relevant staff. Support risk management (ISO 14971) and post-market surveillance activities. Review complaints and adverse event reports to ensure timely investigation and resolution

Qualifications & Experience:

Bachelor/ masters degree in pharmacy, Engineering, Life Sciences, or a related field. Minimum 8-10 years of experience in quality assurance within the medical device industry. At least 3 years in a managerial or supervisory QA role. In-depth knowledge of Class III medical device requirements. Strong understanding of global regulatory frameworks (FDA, MDR, ISO 13485). Experience with interventional medical devices (neurology, cardiology, peripheral) preferred. Certified Lead Auditor (ISO 13485/FDA) is a plus

Key Skills:

Leadership and team management Attention to detail and analytical thinking Excellent communication and documentation skills Strong problem-solving and decision-making abilities project management and cross-functional collaboration

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