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 while driving a culture of quality throughout the organization.

Key Responsibilities




- Quality Management System (QMS)
- Regulatory Compliance
- Internal & External Audits
- Risk Management
- CAPA, NCR & Deviation Management
- Validation & Qualification
- Supplier Quality Management
- Complaint Handling & Post-Market Surveillance
- Product Release
- Training & Quality Culture
- Digital Quality Systems
- Decision-Making Authority

Educational Qualification
- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related discipline.

Preferred:
- Internal Auditor Certification (ISO 13485)

Experience
- Minimum 10 years of experience in the medical device industry.
- Minimum 5 years in a Quality Assurance leadership role.

📌 Quality Assurance Manager (Sanand)
🏢 Biotek Ortho
📍 Sanand