Willem Baelde Email & Phone Number

Arnhem-Nijmegen Metropolitan Area, GE, NL

Nijmegen, Gelderland, Netherlands

Providing consultancy services related to obtaining CE and FDA registration for the GATT hemostatic patch (a class III Medical Device) and the integration of GATT into the global J&J organization.

Boxmeer

Consulting, coaching and interim management in the area of quality and excellence for innovation processes in the technology sector.Customers range from large companies such as Philips, ASML and Barco to scale-up and start-up companies in the high-tech and medical devices sector.Assignments executed have been summarized under the chapter Projects in my.

Eindhoven Area, Netherlands

Provide mentoring for start-up companies on how to set up quality and regulatory management.Clients are high-tech startup companies in the field of medical devices and electronics for consumer and professional use.

Delft, South Holland, Netherlands

Define and implement the Quality and Regulatory strategy for Corsano Medical.Ensure compliance with the EU-2017/745 Medical Devices Regulation and ISO 13485 standard.

Ede, Gelderland, Netherlands

As Management Representative for Philips VitalHealth maintain compliance with the EU-2017/745 Medical Devices Regulation and ISO 13485 standard.Integrate the VitalHealth Quality organization and processes with the global EMR&CM (Electronic Medical Record & Care Management) organization.

Best, North Brabant, Netherlands

Manage the Regulatory team responsible for supporting the New Product Introductions (NPI) in EU, US and Canada for Image-Guided Therapy (IGT) Systems.Under my leadership compliance to the EU-2017/745 Medical Devices Regulation has been ensured for IGT Systems.

Nijmegen Area, Netherlands

Manage the recently certified ISO 13485:2016 based Quality Management System for continued compliance and improved robustness of the medical device start-up company growing onto scale-up.For this project I have assumed the role of Quality Manager and Management Representative which I fulfil in 1 - 2 days per week.

Eindhoven Area, Netherlands

Make the global Quality Management System for Personal Health compliant with the medical device requirements. A fully compliant Quality Management System enables seamless integration of business processes for consumer products and medical devices for professional use.As a first result ISO 9001:2015, ISO 14001:2015 and ISO 13485:2016 certifications have.

Veldhoven, Netherlands

Initiate and coordinate multidisciplinary process improvement project for Industrial Engineering and Sourcing.Contribute to the development of a corporate Supplier Quality Assurance frameworkLead multidisciplinary process improvement teams across sectors, consisting of ASML employees and suppliersBe the competence partner for Industrial Engineering and.

As Senior Consultant I was member of the assessment team of a leading global supplier of smart gas and electricity meters in the UK. Goal of the assessment was to prepare the organization for meeting upcoming customer requirements on quality and logistics of 1,000 PPM and 99% OTD.In the assessment my main contribution was in Quality Testing & Reliability.

- Be a visible, influential leader across the company, advocating quality in all facets of the organization- Lead and develop team of professionals dedicated to quality assurance, quality control and product testing activities across the globe.- Define and implement plans to improve product quality across the entire organization- Represent the Quality.

- Implementation of product development strategy using global outsourced manufacturing partner- Introduction of Design for Six Sigma (DfSS) product development methodology- Implementation of global quality organization in line with DeLIGHT guidelines- Reduction of structural Cost of Non Quality from 5% to 2%- Identification and formation of global.

Manager Quality, Test and Product Engineering for RF-power transistors, highly specialized electronic components as used in mobile telecommunication networks. Main contributions:- Implementation of a more independent and proactive attitude within the department- Structural improvement of the predictability of the product development process, mainly related.

As independent strategic management consultant, in cooperation with consecutively Musch Consulting in Soest and Schel Management Strategen in Laren, responsible for the acquisition and execution of strategic change projects at medium/sized and large companies. Some examples:- Implementation of a new method of product development at a semiconductor.

As Director Global Process Development I managed the global business process development and improvement program. Also I have managed the European Quality and Data Administration department. Main contributions are:- Development of a global Product Innovation Process for data products from initial idea till commercial product.- Significant reduction of.

As Manager Quality Assurance, reporting to the Director Operations, responsible for Quality Assurance and Test Engineering. Main contributions are:- Implementation of Just-In-Time production (lean manufacturing). Just-In-Time production has resulted in a cost reduction of 40% and a reduction of throughput time and working stock of 50%.- Full integration of.

Product development and characterization; Quality management

Masters Degree, Experimental Physics

K.H.O., Commercial Business Administration

Gymnasium Beta, Highschool