Hans Jonker Email & Phone Number

Eindhoven, Nb, Nl

Eindhoven

Sioux has grown to a company with about 650 employees on different locations, each with his own QMS. My role is to align these QMS's to one overall Sioux-QMS, still having room for the differences per location.Before founding my own Argo Consultancy company (with support of Sioux), I have worked about 11 years for Sioux and was one of the first Sioux employees. It is great to see how Sioux has grown from a software detachment company to a system product developer and to be able to support Sioux with my experience about setting up and improving QMS's.

Eindhoven Area, Netherlands

Argo Consultancy is specialized in Quality Management Systems for Medical Devices :- Both sides of the Quality Management System table:.... * Setting up, improving a QMS (ISO-13485 / FDA-QSR).... * Auditing a QMS on compliancy (ISO-13485 / FDA-QSR)- Software Development Procedure (IEC-62304)- Webportals for easy access to the QMS- CE / Technical files- Internal / Supplier Audits- Metrics- Training / Coaching- ISO-13485 Lead Auditor (via DEKRA)- Product Development Training (via Mikrocentrum)

Arnhem

As lead auditor checking the compliance of Quality Management Systems with the ISO-13485 standard for Medical Devices. My specialities are 'Active Medical Devices' and 'Software'.Being a lead auditor for a lot of different companies and training in the continuously changing standards and legislation, has increased my knowledge of e.g.:- ISO-13485 : Medical Devices - Requirements for Quality Management Systems - MDD, IVD, : Medical Device Directives- ISO-14971 : Medical Devices - Risk Management - IEC-62304 : Medical Devices - Software Lifecycle,which I could also use to better implement the Quality Management Systems 'on the other side of the table'.

Eindhoven Area, Netherlands

As part-time subcontractor, setting-up and training of the courses:- Product Development Processes- Quality Assurance in Projects- Document Reviews- Definition and Usage of Metrics

Hechingen / Rastatt

Guiding and consulting Maquet engineers to solve issues via a FDA-compliant CAPA-process, such that these issues will never happen again and so become a continuous improving Quality Management System.

Eindhoven Area, Netherlands

Process Improvement Coordinator in the Development departments of:- Philips HealthTech - Innovation Site Eindhoven (ISE)- Philips Light & Health Venture (Pain Relief Patch)- Philips Healthcare - LABOSYS (Laboratory Information Systems)- Philips Healthcare - IS-ICAP- Philips Healthcare - GXR-Best (IGT)- Philips Healthcare - GXR-Hamburg (IGT)- Philips Healthcare - FIMI-Saronno (Italy)- Philips Healthcare - CIS (Fusion Platform project)Supporting the Philips Healthcare 'System & Software Performance Improvement (SSPI) group with sharing Best Practices between the Business Units worldwide.Doing CMM(I) Assessments all over the world.Guiding Scrum process.

Eindhoven - High Tech Campus

Responsible for restructuring the QMS to be compliant with the FDA 21-CFR-820 and ISO-13485.Owning the programs and executing of Internal Audits, Management Review and CAPA's.Deploying, training and motivating of the QMS to the people.

Solothurn - Switzerland

Supporting Synthes to have a CAPA-system ready for the next future,including FDA- and ISO-Audits.

Leuven - Belgium

Supported Terumo with the preparation for an FDA-Audit on the area of NonConforming Products.The FDA-Audit passed very well.

Eindhoven Area, Netherlands

All kind of work in Software Product Development like:- Process Improvement Coordinator- Quality Officer- People Manager- Verification Manager- Project Leader

Software Engineering in all aspects of embedded software development e.g. Specification, Design, Coding, Testing for e.g. Motion Controllers, Graphical User Interfaces, Test Software, leading small projects.

Design, simulation and implementation of a digital motor control system in a copier.

Ir., Electrical Engineering, Informatics, Bio-Informatics

Activities and Societies: Paradox - Study Association Biomedical Engineering

Post-Hbo, Business Management