related projects. a. Project planning issues b. Compliance Activities (DHF Audits, Traceability, etc.) c. Verification..., FMEAs, etc.) Monitor and maintain DHF requirements in accordance with project timeline and design control requirements...
. 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...
and update of DHF and RMF. Executes changes to quality processes to ensure conformance and continuous improvement. Writes...
organizations (CMOs). Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk...
in the Surgical Division to: Lead small and large NPD projects from start to finish, coordinate Design History File (DHF...
and development;test and report writing and development;execute testing;DHF maintenance;and provide support to other departments... with 3+ years of medical device experience. Familiarity with Design History Files (DHF), Design Master Records (DMR...
detailed Safety, EMC and Wireless verification test plans and test reports. Provide timely DHF deliverables fully compliant...
, environmental, and transportation DHF deliverables, plans, verifications, and validations are compliant, documented, timely...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content integrity...