schedules, DHF management, define objectives and goals for the different, sub-projects/workstreams, and individual team members...’s Project management discipline to develop plans, define scope, design controls, DHF management and manage budget/schedule...
method development, and lead method validation activities. Ensure DHF content integrity, completeness, and regulatory...
and documented Coordinate the planning and development of project DHF and DMR documentation Participate in internal and external...
activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides...
, protocols and reports. Perform DHF/DHR/DMR reviews for product release. Provide quality expertise post market release to the...
throughout the SDLC, such as DHF deliverables, SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cybersecurity...
and other design documentation. Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the...
control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols... with Document Control team to ensure document compliance with PQS standards and DHF regulations. Interfaces and Collaboration...
and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates... and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations. Interfaces...
: Register potential blood donors using the BECS program. Review Donor History Forms (DHF) for completeness;evaluates donors... Response Section (IRS) of the DHF and in Life Trak. Ensures that the donor has read and understands the pre-post donation...