(DHF),risk management files and test protocols. Provide technical guidance and mentorship to junior QEs offshore. Support...
-quality owner for assigned products, ensuring alignment between DHF, DMR, and field-service documentation. Evaluate complex...
, and Manufacturing. Review and approve design documentation including Design History Files (DHF), risk management files and test...
and maintaining project plans and FDA compliant Design history Files (DHF) for each project Managing all aspects of assigned projects...
(DHF) for each project. Manages all aspects of assigned projects to ensure timely completion of tasks while remaining...
specifications for new product development Creating and maintaining project plans and FDA complaint Design history Files (DHF...
and these key external stakeholders. This role is also responsible for compiling and maintaining the Device History File (DHF...
/regression plans, associated test protocols/reports, issue tracking/resolution and auditing Design History Files (DHF...
-mechanical medical device design requirements, risk management, design verification and DHF traceability required. Proficiency...
in the product Design History File (DHF) Communicate proposed modifications to scope, schedule or budget, and influence...