, and approve system architectures, user requirements, and design documentation (URS, PFD, FDS, DHF, traceability matrices...
control activities and ensure documentation supports regulatory readiness. Contribute to DHF, technical documentation...
Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical Files, Software...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
manufacturing, conducting product verification/validation, and developing DHF documentation and test protocols compliant with FDA...
' sleep and respiratory medical devices. Core Competencies Quality Management System (QMS) Design Controls (DHF, DMR... goals and objectives. Own the Design Control process (21 CFR 820.30), ensuring proper documentation of DHF, DMR, and DHR...
, ensuring alignment with design control and DHF requirements. Basic Qualifications: Bachelor’s degree in Packaging...