and these key external stakeholders. This role is also responsible for compiling and maintaining the Device History File (DHF...
projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology...
and Production changes, DHF or Prototype release, Part Author);including developing recommendations for improvement opportunities...
method development, and lead method validation activities. Ensure DHF content integrity, completeness, and regulatory...
/regression plans, associated test protocols/reports, issue tracking/resolution and auditing Design History Files (DHF...
-mechanical medical device design requirements, risk management, design verification and DHF traceability required. Proficiency...
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...
Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards...
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...