Own the Design History File (DHF) for software releases. Review artifacts for completeness and audit readiness...
and maintain high-quality design inputs/outputs, DHF documentation, DFMEA/PFMEA, verification evidence, and change records...
Design History File (DHF), risk management files, and verification/testing strategies to ensure compliance with QMS standards...
, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...
, verification protocols, and DHF content. Executes new devices, processes, equipment, materials, verification and validation...
on materials. Experience working in a regulated design control environment (e.g., DHF, FMEA, risk management). Experienced...
. Initiate and support Veeva change control workflows for product labeling specifications which evaluate design history file (DHF...
, human factors, regular review of DHF, combination product launch activities, device product complaints, and post-market...
(simulation, prototyping, bench testing, performance testing) Author and maintain technical documentation supporting DHF...
, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...