Senior Design Quality Engineer
, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF...
, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF...
, specifications, and Design History File (DHF) content. Support intellectual property creation and technical documentation. Ensure...
and Design history Files (DHF) for each project Managing of all aspects of project to ensure timely completion of tasks...
with generating, maintaining, and updating Design History Files (DHF) for new and/or existing products. - Completes all work...
work will focus on performing Design History File (DHF) remediations, writing Procedures and Test Method Development.... Projects Include: Project 1 – Assisting with Developing PRCDs for Internal DVT Project 2 – DHF Remediation for Commercial...
and translate findings into subsystem requirements. Ensure control measures flow into the Risk Management File and DHF. Translate...
, DHF, traceability matrices) through data gathering, drafting, and revision. Contribute to assembling and testing...
and DHF documentation. Perform hardware/software/lab tests;Ensure compliance with ISO 13485 standards. Communicate status... and DHF documentation. Perform hardware/software/lab tests;Ensure compliance with ISO 13485 standards. Communicate status...
. Maintain requirements traceability and Design History File (DHF) documentation. Perform hardware, software, and laboratory...
Support Design History File (DHF) remediation and gap assessments as needed Ensure traceability, consistency, and compliance... Aptitude and Skill Set: Direct experience with DHF remediation, CAPA-driven documentation updates, or site-readiness projects...