Jens Burkert - My Services - Jens Burkert

Certified Test Manager (ISTQB)
Certified Project Manager (IHK)

Certified Test Manager (ISTQB)
Certified Project Manager (IHK)

"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.