, Serve as the service-quality owner for assigned products, ensuring alignment between DHF, DMR, and field-service...
for single use devices and those containing Electronic Medical Equipment. Experience with drafting and maintaining DHF and DMR...
documentation for the project Design History File (DHF). Collaborates on the development of inspection methods Initiates design...
, and Manufacturing. Review and approve design documentation including Design History Files (DHF), risk management files and test...
and risk-based decision making Familiarity with DHF, DMR, HA, pFMEA, dFMEA, RMP/RMR/BRA Risk as part of design change...
and maintaining project plans and FDA compliant Design history Files (DHF) for each project Managing all aspects of assigned projects...
(DHF) for each project. Manages all aspects of assigned projects to ensure timely completion of tasks while remaining...
specifications for new product development Creating and maintaining project plans and FDA complaint Design history Files (DHF...
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...