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| Name | Hans Jonker | |
| Date of Birth |
29 May 1958 |
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| Title | Ir. (Ingenieur) / MSc (Master of Science) | |
| Education |
- Master in (combinations of) Electronics, Biomedical Techniques and Computer Science (Technical University of Twente) |
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| Experience |
17 years: Setting up Quality Management Systems (ISO-13485 / FDA / CMMi) |
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Process |
Achieved with 2 organizations a very successful ISO-13485 certification Brought 3 organizations to the CMM(I) level 2, which operate according to that Quality System and still continuously improve !! Performed 5 assessments on CMM(I) level 2/3. |
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| Auditing | As ISO-13485 lead auditor performed about 40 audits As QA-Officer completed 2 years of auditing in development projects. As Process Improvement Coordinator guided a lot of QA-Officers to structure their auditing process. |
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| Project Management |
As a Project Manager organized 2 very successful projects. As a Process Improvement Coordinator guided a lot of Project Managers to structure their project management process. |
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| International Experience |
Worked 4 years in Germany and 3 years in Italy. Assessments done in Taiwan, Singapore and U.S.A. |
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| Courses |
Medical Device (ISO-13485, Risk, Vigilance, CE-mark, FDA) |
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| Soft Skills | Communication Social / Interested in people Optimist Drive / Energy |
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| Expert in |
Setting up Quality Management Systems Software Development processes Change Management |
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| Hobbies |
Running |
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More |
