Name Hans Jonker  
Date of Birth 

29 May 1958

 
Title Ir. (Ingenieur) / MSc (Master of Science)  
Education 

- Master in (combinations of) Electronics, Biomedical Techniques  

  and Computer Science (Technical University of Twente)
- Organizational Management;
  (Institute for Career and Development; night school)

 
Experience 

17 years: Setting up Quality Management Systems (ISO-13485 / FDA / CMMi)
7 years:   Lead Auditing ISO-13485
8 years:   Running own business
2 years:   Quality Assurance Officer
1 year:     People Manager (HRM)
15 years:  Software Development (Developer, Tester Manager, Project Manager)
(31 years total:  Product Development)

 

Process
Improvement

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.
 
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.
 
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.
 
International
Experience 
Worked 4 years in Germany and 3 years in Italy.
Assessments done in Taiwan, Singapore and U.S.A.
 
Courses 

Medical Device (ISO-13485, Risk, Vigilance, CE-mark, FDA)
Technical (Software, User Interfaces, Testing, …)
Process Improvements
Change Management
Auditing
Soft Skills
SCRUM (Master)
Prince 2

 
Soft Skills  Communication
Social / Interested in people
Optimist
Drive / Energy
 
Expert in

Setting up Quality Management Systems
Auditing

Software Development processes

Change Management
Peer Review
Quality Assurance
Project Management
Supplier Management

 
Hobbies

Running
Fitness
Cycling

 

More
Information

Short CV

Detailed Courses / Jobs