with external development partners while maintaining DHF ownership. Experience leading technical efforts as Technical Core Team...
with external development partners while maintaining DHF ownership. Experience leading technical efforts as Technical Core Team...
. Ensures comprehensive Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR...
Analysis to identify impact of change - specifically Changes impacting DMR, and DHF Review incoming change requests...
process DHF creation and support of audits of our Design Control process and documentation. Experienced with preparation...
standards such as FDA guidance on cybersecurity for medical devices. Prepare and maintain the software design history file (DHF... for medical devices. Prepare and maintain the software design history file (DHF) in alignment with FDA and international...
assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. Develop...
and update of DHF and RMF. Executes changes to quality processes to ensure conformance and continuous improvement. Writes...
and the Design History File (DHF) and Data Integrity as required. Provide oversight and guidance for risk management file...
in the Surgical Division to: Lead small and large NPD projects from start to finish, coordinate Design History File (DHF...