Quality Assurance Manager

Company: Chetan Meditech Pvt. Ltd. (BIOTEK)

Location: Sanand GIDC, Gujarat, India

Department: Quality Assurance

Company Overview:

Chetan Meditech Pvt. Ltd. (BIOTEK) is a certified medical device manufacturer specializing in orthopedic and sports medicine implants and instruments. The organization operates in compliance with ISO 13485:2016, EU MDR 2017/745, and applicable global regulatory requirements.

Position Summary:

The Quality Assurance Manager is responsible for establishing, implementing, maintaining, and continuously improving the Quality Management System (QMS) in accordance with ISO 13485, applicable regulatory requirements, and company quality objectives. The role ensures that all medical devices are designed, manufactured, tested, packaged, sterilized, and released in compliance with applicable regulatory and customer requirements...