reports that support product validation and performance assessment. 5. Familiarity with design history files (DHF), device...
and maintain customized product specifications and Design History Files (DHF), while driving technical reviews with supportive data...
. Contributes to the Design History File (DHF). Ensures a quality focus and that customer needs are met. Actively leads development...
History File (DHF). Coordinate with cross-functional teams to ensure timely completion of testing activities. Education...
. Document clinical studies plans/ reports for inclusion into the Design History File (DHF) project. Interact as the primary...
PFMEA and implement mitigation strategies for high-volume production risks. Maintain DHF and DMR documentation...
requirements. Maintain required project documentation, including DHF and DMR content. Operational Excellence: Identify...
, and updates as required. Support the creation and maintenance of Design History Files (DHF) and other records...
analysis and DHF maintenance), using advanced inspection, testing, and statistical analysis methods to ensure product precision... for product changes, design change analysis, and Design History File (DHF) maintenance. Demonstrates strong expertise in risk...
plans and FDA complaint Design history Files (DHF) for each case Ensures timely completion of project tasks, as assigned...