(DHF), including Design Inputs, Outputs, and product specifications. Lead and maintain risk management artifacts...
and statistical analysis. Responsibilities: Identifying gaps in the acquired company's DHF to Work Instructions and SOPs... Development system knowledge through delivery of high quality, high impact deliverables. Taking DHF data from newly acquired...
(DHF), including Design Inputs, Outputs, and product specifications. Lead and maintain risk management artifacts...
and FDA complaint Design history Files (DHF) for each project Manages all aspects of assigned projects to ensure timely...
Requirements (GSPR). Ensure Design History File (DHF) content completion, integrity, and compliance with regulatory and standards...
and maintain high-quality design inputs/outputs, DHF documentation, DFMEA/PFMEA, verification evidence, and change records...
facility. Assignments may take place at one facility or rotate among several of the three DHF facilities, depending...
in failure mode and effects analysis (FMEA). Knowledge of medical device regulatory submissions (e.g., supporting DHF, DMR...
with Design Control documentation (DHF, RMF) Why You’ll Love It Work on innovative combination products impacting patients...
all system-level documentation complies with ISO 13485 and FDA 21 CFR 820. You are the guardian of the Design History File (DHF...