DeAngeli GmbH - Quality Services


Keywords - Overview


  • Quality approach ( eCompliance) within global IT Projects
  • Legacy Review, Remediation and Computer System Validation for Medical Device Manufacturing 
  • Quality- and Risk Management (FMEA) in validated environments
  • Compliance with FDA 21CFR11 - 21CFR820 - ISO13485 - ISO14971 - ISO 62304 - GAMP5
  • Development of SOPs
  • Interactive personality with ability to operate effectively in an internation environment

  • Strong quality focused and customer oriented 
  • Calm even in hectic situations
  • Maturity to deal and interactt with a wide variety of people at all levels
Core Skills:
  • Bringing your environment to a validated status by seriuos Quality- and Validation planing in GxP environments with risk-based approach
  • Total Quality Management Certified
Prodisc Cervical by Synhtes
  • GCP (Good Clinical Practice) Certified
  • Profound knowlwdge in FDA regulations and other Guidelines, such as: 21CFR11, 21CFR820, ISO13485, ISO14971, ISO62304, GAMP5, ITIL

  • GMP on Medical Device manufacturing (Implants & Instruments)
  • Team Leading with very good interpersonal-, communication- and problem solving skills
  • Drug development processes, Pharmacovigilance and drug safety

CSV Engineer, Lead PQM, Project Manager, Quality Manager, IT Team Manager, Senior Application Manager, IT Manager, ERP Programmer, IT Coordinator,