"Project success with team spirit, experience and a good understanding"

Planen Steuern Koordinieren Testen Berichten - Mein Angebot als Testmanager

Plan

  • Project, budget and time table management
  • Preparation of validation plans, risk assessments and conceptual documentation

Control

  • Create metrics to track project progress
  • Monitoring and control of project progress

Coordinate

  • Management of project teams with more than 25 employees
  • Organization and team motivation of project team members from different companies and disciplines

Reporting

  • Regular information on the progress of the project
  • Timely notification of potential risks or delays

Planen Steuern Koordinieren Testen Berichten - Mein Angebot als Testmanager

Testing

  • Creation of test specifications and test scenarios according to product specifications
  • Creation of CSV documents including plan, FMEA, IQ, OQ, PQ, report
  • Execution and optimization of (automated) test procedures
  • Review of documents and specifications

Project management and Test management

  • Budget-, resource- and time planning
  • Monitoring, control and communication of project progress
  • Lead of project teams
  • Creation of CSV documentation including
    Test Plan, FMEA, DQ, IQ, OQ, PQ, Traceability Matrix, Test Report
  • Create and perform (automated) black box and whitebox test cases

Quality Assurance Medical Devices

  • Quality assurance in accordance with FDA requirements 21 CFR Part 11 and 510K
  • Creation of test specifications and test scenarios according to product specifications, with a view to all possibilities and eventualities of interaction between device, program and device user
  • Execution and optimization of (also automated) test sequences beyond module and specification limits
  • Review of product specifications and programs

 

Validation of laboratory systems

  • Preparation of validation plans, risk analyses (FMEAs), qualification protocols (IQ, OQ, PQ), validation reports
  • CSV, GAMP 5
  • MES (Siemens)
  • LIMS (Labware)
  • Preactor Scheduler (Siemens)

Project languages

German
English
(fluent, business fluent)

Locations

Prefers Mannheim and 100 km surroundings - other locations and foreign countries on request.

kontakt@jens-burkert.de

You would like to know more about my services?
I am looking forward to your request.