Contribute to design history file (DHF) creation including design review meetings, phase signoffs, and final transitions... to manufacturing. Learn and support the design control process (DMR, DHF, Technical Files, etc.) Create drawings, documentation...
and review of technical documentation including Design History Files (DHF), Product Requirement Documents (PRD), and Test...
risk management guidance during New Product Introduction (NPI) activities Maintain and update Design History File (DHF... traceability of design changes, risk mitigation activities, and post-market surveillance data within the DHF to support audits...
relative to Field Safety Events regulations. Oversee the improvement/corrective/preventive activities to DMRs, DHF/Tech Files...
evaluations (DOEs) and providing technical input for justification of project and design. Responsible for contributing to the DHF...
for DHF(design history file) and to support FDA submissions. You will have the opportunity to work on challenging projects...
activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides...
frameworks such as ISO 13485, FDA QSR, IEC 60601, ISO 14971, ASTM standards, DHF, FMEA, and V&V protocols. Experience...
as all West Virginia, DHHR/DHF/OSA policies and procedures. The candidate must have an active status with current Licensure...
as all West Virginia, DHHR/DHF/OSA policies and procedures. The candidate must have an active status with current Licensure...