Job Summary :

The Senior Quality Assurance Engineer (Design Assurance) is responsible for providing oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements.This role plays a key part in guiding design controls, facilitating design transfer, and managing risk documentation across medical device product lines (Class I and Class II 510(k)). The engineer will ensure that all processes and documentation meet FDA and ISO standards, and that design changes are properly controlled and documented.

Roles & Responsibilities :

• Conduct end-to-end DHF audit and gap assessment , including:
  
  
  
  
  • Design & Development Plan
  
  
  • User Needs
  
  
  • Design Inputs & Outputs
  
  
  • Design Verification & Validation (V&V)
  
  
  • Risk Management Files (ISO 14971)
  
  ...