Job Title: Design Documentation & Validation - Senior Executive. Department: Endoscopy and Women Healthcare
Location: Vapi, Gujarat
Reports To: Manager / Senior Manager – Endoscopy and Women Healthcare
Job Purpose:
To prepare, maintain, and manage design documentation throughout the medical device product development lifecycle, ensuring compliance with global regulatory requirements and quality management systems. The role involves Design History File (DHF) management, Design Verification & Validation (V&V), Risk Management, Technical Documentation, and regulatory submission support in accordance with ISO 13485, ISO 14971, MDR, FDA, CDSCO, and other applicable medical device standards.
Key Responsibilities:
1. Design Documentation & Design Control
Prepare, review, and maintain Design History File (DHF), Device Master Record (DMR), Technical Documentation, and Design Control documents throughout the product lifecycle.
Develop and maintain Desi...