23 Oct
|
Saaki Argus And Averil Consulting
|
Pune
23 Oct
Saaki Argus And Averil Consulting
Pune
The DHF Remediation Engineer will be responsible for reviewing, assessing, remediating, and updating Design History Files (DHF) and Design Control documentation for medical devices to ensure compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Control requirements. The role requires solid expertise in design controls, risk management, traceability, verification and validation documentation, technical file remediation, and cross-functional collaboration with R&D;, Regulatory Affairs, Quality, and Clinical teams.
Mandatory Skills -
- DHF Remediation
- Design Controls
- Technical Documentation Review
- Requirements Traceability
- Verification & Validation Documentation
- Root Cause Analysis
- Medical Device Product Development Lifecycle
📌 V&V with DHF Remediation (Contract) (Pune)
🏢 Saaki Argus And Averil Consulting
📍 Pune