and regulatory compliance. Prepare and review Design History Files (DHF), Device Master Records (DMR), and related technical... validation. Hands-on experience leading design reviews and addressing CAPA or audit findings. Knowledge of DHF/DMR structure...
Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards...
). Experience with design controls and documentation in a regulated environment (FDA, ISO 13485), including DHF creation, risk...
, and Manufacturing. Review and approve design documentation including Design History Files (DHF), risk management files and test...
dress code applies as well as all West Virginia, DHHR/DHF/OSA policies and procedures. The candidate must have an active...
Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA...
reviews, authoring Design History Files (DHF), Risk Management Files (RMF), and validation documentation. ● Experience...
of Design History File(DHF) documentation for capital and disposable medical devices, including design plans, design inputs...
completion within the medical device sector. Coordinate Design History File (DHF) transfers and support both new and existing...
Design history Files (DHF) for each project Manage of all aspects of project to ensure timely completion of tasks...