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Work Background
SinclairInterim Manage AQTIS staff Class III device, Supplier Controls, CAPA resolution, Change Management
Sep. 2020 - Dec. 2020The Randstad, NetherlandsNice to work with Motivated staff in a Booming company, really enjoyed sharing experience and improving processes in cooperation using what is present. Started a journey on improving supplier controls, CAPA resolution, and Change management. Where I am confident the crew will maintain and improve the processes. Grateful for the Opportunity working with this staff on a Class III device.
QUOIUMQUOIUM
Aug. 2020NetherlandsQUOIUM® is specialised in tailored Quality Management Systems for the Medical Device Industry, by its Core documents. Haveitmade Companies is participating in QUOIUM
Oriel STAT A MATRIXPrincipal Consultant, Quality and Regulatory Affairs
May. 2020 - Sep. 2022EuropeOriel STAT A MATRIX provides life sciences organizations with consulting, training, and audit support to achieve compliance with US FDA and global regulations like EU MDR and EU IVDR. Core Values:
Happy Employees Do Great Work for Customers
Doing the Right Thing for Mutual Success
Diversity is a Competitive Advantage
Take the Long View
Give Back to the Community Looking Forward on Sharing Experience by doing the Right Thing for Mutual Success
ASMLSQE Team Lead starting lift off Supply Chain and Quality for Handling and Tooling
Oct. 2019 - Nov. 2020North Brabant, NetherlandsInspiring Environment (again in this incredible company). EnjoyedTrying to make the Difference in and very technical Eco-system. Very inspiring team that allowed me to be the Black sheep, improving Quality and Supplier relations, seeking cooperation and trust. I think we succeeded as team to find each other in diversity.
OSUS Open Source Ultrasonic Scanner CooperstionEntrepreneur
Mar. 2019EuropeSharing Open Source Tools and Brainstorms on better Tools using AI (Artificial Intelligence) to improve Ultrasonic Scanning. Sustainable Manufacturing and products ideas. Use deep learning and Finding Participants and funding to realize idea’s.
PhilipsNPI New Product Introduction and Supplier Development business responsible
Aug. 2016 - Dec. 2017Eindhoven Area, NetherlandsBusiness responsible for NPI (New Product Introduction) focussing on Consumer Lifestyle Class II connected medical propositions or Products. Responsible for all tier supplier including Finished Goods ODM co-developments. Create long term relations realizing and enabling current and extended programs. Make sure in and outsourced portfolio or product propositions are within expected timeline quality cost budget as aligned with stakeholders. Team up with marketing, development and procurement forging fact based agreements and contracts. Support change management based on impact analyses and business cases. Establishing long term relations with manufacturing sites and suppliers while insourcing and outsourcing according to strategy. Setup working platform with Supplier for Collecting DHF/DMR APQP Approbation data and Capital for suppliers first Medical Device Class II ISO13485 portfolio production and compliant documentation. As NPI we outsourced from early phase design and have part of the development done outsourced. Realised a Manufacturing 4.0 abroad to gather early stage research data. Made a Risk Based CAPEX investment plan enabling escapes to avoiding high Capital investments when the project is not solidified yet. Leading un-experience audit teams to evaluate and report at suppliers local Management, Engineering, Production, Supply Chain management.
DEKRAFreeLance Auditor ISO
Jun. 2016 - Mar. 2021NetherlandsFocus upgrade and recertification 13485 and Unannounced Audits
PhilipsLead Auditor external auditor ISO 9001 and ISO 13485
Dec. 2014 - Dec. 2017EMEAOrganize and Cross sectional Business audits for Finished goods and higher tiers.
Coordinate the Follow up and improvement actions @ the Suppliers. Support 3rd party governmental audits.
Maintain Internal Philips ISO13485 certificate and working experience with Class II medical device by continuos training.
PhilipsProjects Manager & Change Lead for Medical Consumer Electronic
Jun. 2014 - Dec. 2017Innovation Site EindhovenRealizing cost down by New Product Introduction and Manufacturing Transfers of regulated medical product portfolio’s.
Shape, expand and maintain New and existing markets within new and existing programs.
Effective Change Management with the ability to adapt and improve the approach based on circumstances using clear impact analyses and business cases.
Team up with corporate procurement and business stakeholders shaping Global supply base strategy.
Change management. Escalations, risk mitigation, Stakeholder management. Enable new markets by guiding and interfacing between innovation and suppliers in country approbation and country introductions
Gain trust, influence and build strong relationships in and outside the Business.
HaveitMade CompaniesGlobal Expert in Quality, Auditing, and Regulatory Compliance — Delivering Results from Anywhere
May. 2010anywhereWith over 25 years of global experience in quality and regulatory management, I provide freelance and interim expertise in auditing, process improvement, and regulatory compliance. I create and implement process architectures, conduct training, and lead cross-functional teams to drive success. I work comfortably in dynamic, global environments, fostering team spirit or shaping organizational structures, from in-house solutions to buyouts.
Have it Made CompaniesPrincipal Owner
May. 2010EuropeAs a Client first Organisation, we strive to keep quality top of mind. While you undergo rapid changes necessary to meet national regulatory or business deadlines, you include a limited hire of consultants, followed by a project-based ramp period with targeted completion. Let us know if we can help to build the Architecture of your next project. Enabling a risk based continuous controlled change culture based on your business needs.
Reliable LED ltdDirector Industrialization, sourcing and manufacturing
Nov. 2009 - Jan. 2016Netherlands, ChinaIndustrialization responsible new product introduction and manufacturing startup in close cooperation to R&D and world wide partners. We established own products, source base, manufacturing and part of the design with partners in Asia and Europe. We make special solutions for our customers using certified, safe and high performance parts or products. When you have a desire for lighting and a lust for energy savings, we can realize the product fit for your business.
Canon Production PrintingNew Product Development
Jan. 1992 - Jan. 1998South of Netherlands with interaction to Europe and USNew product architecture design and engineering. Enjoyed the luxury to experience basic research to Lifecycle extension. Interaction to a wide scala of commodities and special techniques exloered in more than 6 years. The goal was experience Research and Development in all stages. Technical courses: plastics, rubber technology, gears and transmission, silent constructions, 3Dcad , Plastic Modeling, coaching courses, self-reflection.
Océ TechnologiesIndustrialization teamleader
Jan. 1990 - Dec. 2010Europe, west and east, US and Asia.2003-2007 Managing outsourcing to mainly China and Singapore, Malaysia in South-East Asia. Retransfer modules from contract manufacturing partner Czech republic to Netherlands. Starting account responsibility Sanyo Japan. 2008 Entered colorwave project in cooperation with Flextronics Penang.
Started internal consultancy to Asian team for transfer from China to Malaysia sopped all other activities till autumn. Cleanroom process and part improvement with Japanese partners. 2009 consultant / team-leader on site full Asian team for transfer from China to Malaysia.
Before 2003 several outsourcing, quality and logistics related projects in with main focus on US and Eastern Europe for partners combined the existing supply base by transfers of parts of factories new contacts....
Military serviceAdvice on percussion and stage management
Jan. 1989 - Jan. 1990whole Europe with a focus on the NetherlandsAdvize on organization classical Orchestra percussion. Solo and added percussion.
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