of implantable device DHF's to ensure compliance. Required Qualifications: Bachelor's degree in mechanical engineering, Biomedical...
and oversee content of the Device Master Record (DMR) for accuracy and compliance. Audit Design History File (DHF...
History Files (DHF) Quality & Compliance Perform work in compliance with ISO 13485, QSR, and internal quality systems...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content completion...
, including evaluations of Design History Files (DHF) and Risk Management Files (RMF). Develop, review, and approve controlled...
History Files (DHF) Quality & Compliance Perform work in compliance with ISO 13485, QSR, and internal quality systems...
. Ensure compliance with FDA QSR, ISO 13485, ISO 9001, and GMP requirements. Maintain Design History Files (DHF) and support...
, revisions, approvals, and DHF/DMR-style linkages to parts and changes. Regulatory & Compliance Data UDI / UDI-DI data...: controlled documents, revisions, approvals, linkages to parts (DHF/DMR style scenarios as applicable) Change workflows (e.g...
and creating DHF deliverables like Test Procedures and Test Reports. He/She will collaborate across engineering disciplines...
. Develop and maintain firmware documentation to support regulatory submissions, design history files (DHF), and traceability...