Staff Engineer, Spine
product development. Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...
product development. Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...
, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF...
Design History File (DHF) and alignment with FDA Quality System Regulation (QSR) and ISO 13485 requirements. Participate...
. Create and maintain DHF documentation, such as Design & Development Plans, Risk Management Files, and Design Reviews... & Qualifications Experience with DHF Knowledge of Design Review processes Verification and Validation expertise Understanding...
, specifications, and Design History File (DHF) content. Support intellectual property creation and technical documentation. Ensure...
and Design history Files (DHF) for each project Managing of all aspects of project to ensure timely completion of tasks...
analysis and DHF maintenance) and using advanced inspection, testing, and statistical analysis methods to ensure product... change analysis, and Design History File (DHF) maintenance. Demonstrates strong expertise in risk management by devising...
corrective/preventive actions. Ensure integrity and completeness of the Design History File (DHF) and alignment with FDA...
Design History File (DHF), risk management files, and verification/testing strategies to ensure compliance with QMS standards...
stakeholders. Participate in design reviews and contribute to design history file (DHF) documentation. Required Qualifications...