Senior Quality Engineer- Combination Product Development
organizations (CMOs). Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk...
organizations (CMOs). Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk...
to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA...
in the Surgical Division to: Lead small and large NPD projects from start to finish, coordinate Design History File (DHF...
compliance of the design history file (DHF), and support transition of the design project into sustaining engineering. Support...
File (DHF) and associated documentation. Responsible for quality oversight and approval of software product development...
of the Design History File (DHF) and associated design control documentation for medical device software. Responsible...
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...
, such as DHF deliverables, SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cybersecurity. Maintain knowledge of the...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content integrity...