About This Job
Meril
Location:
Vapi, Gujarat, India
Work Mode:
In office
Industry:
Medical Device,Medical Equipment Manufacturing,Medical Practices
Job Description
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
- 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 Design and Development Plans, User Requirements, Design Inputs, Design Outputs, Design Review records, and Design Change documentation.Prepare Engineering Change Orders (ECO), Engineering Change Notices (ECN), and maintain document revision history.Ensure complete traceability between design inputs, outputs, verification, validation, and risk management activities.Maintain document integrity in accordance with document control procedures and quality management systems.
- Design Verification & Validation (V&V;)
Prepare Design Verification and Validation plans, protocols, reports, and summary documentation.Coordinate execution of verification and validation activities with R&D;, Quality, and Testing teams.Develop and maintain Requirement Traceability Matrix (RTM) to demonstrate compliance with product requirements.Review test results and ensure documentation adequately su
📌 Design Documentation (Vapi)
🏢 Meril
📍 Vapi