projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology...
History File (DHF) and technical documentation requirements. Why join Hologic? We are committed to making Hologic the...
in the product Design History File (DHF) Communicate proposed modifications to scope, schedule or budget, and influence...
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...
completion within the medical device sector. Coordinate Design History File (DHF) transfers and support both new and existing...
to ensure reliability, environmental, and transportation DHF deliverables through Design Control process, plans, verifications...
Design history Files (DHF) for each project Manage of all aspects of project to ensure timely completion of tasks...