for components, products and processes Identify Design History File (DHF) enhancements / updates for specific device presentation...
verification and DHF traceability required. Proficiency with test execution, deviation reporting and management, data review...
(i.e. BOMs, item masters, DHF, DMR, etc.) Excellent communication skills (oral and written). Able to work independently...
., CAPAs, DHF remediation, requirements traceability). Skills Proficiency in usability engineering tools and techniques...
during NPI. Works with project teams to produce DHF reports, verifications and validations are compliant, documented...
as needed for cross-functional stakeholders. Provide guidance and impact assessments for Change Control, including DHF/RMF assessments...
as needed for cross-functional stakeholders. Provide guidance and impact assessments for Change Control, including DHF/RMF assessments...
for major & reference markets (US/Canada, EU, AUS) Provide strategic planning throughout the product lifecycle (DHF & change...
with the creation of project plans and Design history Files (DHF) for each project Partnering with engineers on all aspects...
documentation of DHF’s, DMR’s, and DHR’s for each project in group according to Globus quality policy and all FDA...