History

History roots

Medtronic Period
2005-2015

Medtronic Bakken Research Center Maastricht 
&
Medtronic CardioVascular Operations Kerkrade

Challanges presented

Medtronic is a market leader in the medical device industry. The Bakken Research Center was founded in 1987 to support the development of medical devices. Nowadays the BRC mainly supports clinical studies. The CardioVascular facility in Kerkrade is a production facility supplying mainly cardio perfusion sets to hospitals all over the globe.  

Different QA roles to support:

The development of products for Neuro, CRDM, Cardiovascular, etc.
In-depth knowledge on the specific device regulations and the performance of the different types of stimulation wires, stimulators, accessories and custom-builds for patients that have specific material allergies.

The development and maintenance of processes. 
Qualification and validation of production processes related to sealing, monitoring andcleanroom validation.
Supporting and conducting different types of audits.

The implementation of new legislation, systems and other innovation projects.
Project chair for the implementation of the, at that time, new MDD (2010) for Europe.
Developer of the first risk-based CAPA system in the Netherlands.
Project council member for several global innovation initiatives.

Value gained

Before I started working for Medtronic, I worked for a few small companies where I could develop my quality and personal skills. What they could not offer me, Medtronic did. As a global market leader in the medical device industry Medtronic opened a completely new world for me. I could tap into the vast knowledge that was available, enabling me to further develop my knowledge and skills providing me with almost unlimited knowledge and enabled me to add for the first time of my life, value to the life of others.

Philips Period
2016

Philips Healthcare Eindhoven

Challanges presented

Philips was my first customer in a consultant role. I supported the development assessment and implementation of a global quality system. Something I also did for Medtronic. Philips, also a global and important player in their field of expertise, provided me with a different work experience than working for Medtronic. The way of working and the brilliant but different perspective on their quality system and its interaction were refreshing.

Value gained

Philips supported and guided me into the consultant community. I greatly value the time and effort Philips invested in me. Philips let me discover my boundaries and provided me with a fresh new vision on quality. They also planted the seed for QMS Guru.

Chemelot InSciTe Period 
2017-2019

Chemelot InSciTe 
Institute for Science and Technology atGeleen 

Challanges presented

InSciTe is part of a public-private research and technical validation institute. They house academic and commercial parties to allow them to bundle their strengths in the development and application of biomedical materials. InSciTe provides resources such as building/officespace, cleanrooms, equipment, systems, knowledge and human resources to those parties. Main role: QA/RA manager.

Responsible for:

The quality system.
Created and implemented a brandnew QMS based on ISO 13485:2016 and obtained Dekra certification 7 months later. What makes this  QMS unique is the fact that clients can own it, partly or entirely. This approach resulted in Dekra certifcation of 2 commercial partners and a third who received a temporary manufacturing license.

Enabling quality and regulatory support to the different academic projects and private companies. 
- Project support and training on engineering and QMS system challenges
- Academic project coaching
- Fulfilling role of QA/RA manager for clients
- Project resource planning 
Leading QA/RA facilator to ensure that within those 2 years, two different academic medical device projects, two medical device companies and one cell therapy company reached the clinical trial phase.

Creating the quality management system framework for the next "InSciTe" called Medace
Responsible for all quality aspects related to the new to build facility, cleanrooms and laboratories for biomaterials and medical devices.

Value gained

I rediscovered:
- my rich and diverse knowledge
- my unchanged true passion: engineering and enabling others to grow
- that there are no boundaries, the only limitation lies within yourself.
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