submissions (INDs, IMPDs, BLAs) and responses to Health Authority inquiries as needed. · QA lead for Design History File (DHF...
development Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project Managing...
and release schedules. Create and maintain DMR/DHR/DHF records and files and all supporting documentation through the project...
defines and advances V&V strategy and standards across multiple product lines, ensuring that methods, processes, and DHF...
File (DHF), risk management files, and verification/testing strategies to ensure compliance with QMS standards. Own...
and maintain documentation required for design history files (DHF). Job responsibilities within our organization are dynamic...
history files (DHF) and production records. Provide regular updates on the status of NPI tooling and process validation...
, testing documents and DHF/DMR records. EDUCATION and/or EXPERIENCE: Bachelor's degree in engineering or related field...
and maintain key Design Control documentation including Design History Files (DHF), Risk Management Files, trace matrices...
-quality owner for assigned products, ensuring alignment between DHF, DMR, and field-service documentation. Evaluate complex...