Quality Executive - QAQC at S3V Vascular Technologies

About the Company

S3V Vascular Technologies Limited is an ISO 13485 certified manufacturer specializing in Neurovascular, Cardiovascular medical devices, and Critical Care products. Its product range includes Clot Retrievers, Neuro Catheters, Cardiac Catheters, and Drug Eluting Stents. The company is establishing an integrated manufacturing unit in Chennai’s Medical Device Park for Neuro, Cardiac, and Peripheral intervention devices. With a robust focus on innovation, clinical safety, and regulatory adherence, S3V aims to provide advanced healthcare solutions compliant with global standards such as ISO 13485, EU MDR, US FDA, and CDSCO.

Key Responsibilities

• Managing and documenting CAPA, Deviations, Incidents, Change Controls, and related quality system documents.
• Investigating customer complaints to identify root causes and corrective actions.
• Ensuring cleanliness and environmental condition compliance in manufacturing areas.
• Preparing data analysis reports to support quality decisions.
• Drafting Validation Protocols and Reports for product processes.
• Overseeing QMS preparations for introduction of new products.
• Reviewing and verifying on-line documentation accuracy.
• Ensuring adherence to Standard Operating Procedures (SOPs) on the shop floor.
• Supporting documentation and participation during equipment qualification activities.
• Validating external calibration reports for accuracy and compliance.

Qualifications and Skills

• In-depth knowledge of quality management systems, principles, and best practices.
• Awareness of relevant regulatory standards and industry compliance requirements.
• Certification in quality management is required.