, and updates as required. Support the creation and maintenance of Design History Files (DHF) and other records...
plans and FDA complaint Design history Files (DHF) for each case Ensures timely completion of project tasks, as assigned...
PFMEA and implement mitigation strategies for high-volume production risks. Maintain DHF and DMR documentation...
analysis and DHF maintenance), using advanced inspection, testing, and statistical analysis methods to ensure product precision... for product changes, design change analysis, and Design History File (DHF) maintenance. Demonstrates strong expertise in risk...
Design history Files (DHF) for each project Manage of all aspects of project to ensure timely completion of tasks...
requirements. Maintain required project documentation, including DHF and DMR content. Operational Excellence: Identify...
intent. Maintain documentation within DHF and ensure all activities meet regulatory and internal compliance expectations.... Must-Have Skills Strong engineering background with hands-on experience in design controls, V&V, DHF documentation, and risk...
to ensure alignment with design intent. Maintain documentation within DHF and ensure all activities meet regulatory... controls, V&V, DHF documentation, and risk management. Ability to read and interpret mechanical drawings. Solid...
intent. Maintain documentation within DHF and ensure all activities meet regulatory and internal compliance expectations.... Must-Have Skills Strong engineering background with hands-on experience in design controls, V&V, DHF documentation, and risk...
and approve Design History File (DHF) documents, ensuring compliance to design control requirements. EDUCATION & EXPERIENCE...