Ing. Johannes (Hans) van Leuven
Selbstständig, Auditor, Haveitmade Companies
Lent, Niederlande
Über mich
Curious, open and feel at home in a dynamic environment. Can establish and implement from scratch or stalemate situation processes that are effective measurable and maintainable. Comfortable with relatively vague requirements Appraised for finding win win strategies Passioned on empowering and shaping teams for achieving goals in highly complex regulated products or processes. Having an independent view, acting fact based strategy driven seeking win win factors at the internal and outsourced activities. Experienced the benefits of cross-functional and global teams Made a habit of Participating, leading and guiding in multiple teams globally. Management experience for complex integrated products and for regulated medical consumer products and governing capital Investments and agreements. Key strengths include process improvement with focus on time to market, strong analytical and intercultural skills.
Werdegang
Berufserfahrung von Johannes (Hans) van Leuven
Bis heute 2 Jahre und 8 Monate, seit Sep. 2021
Auditor
Haveitmade Companies
Process assessment suppliers inspired by VDA 6.3
Bis heute 3 Jahre und 9 Monate, seit Aug. 2020
Upgrade Core and Basic QMS Documents 4 Scale up and Startup
QUOIUM partnership Haveitmade Companies
Bis heute 5 Jahre und 4 Monate, seit Jan. 2019
QARA consultant realising a Compliant QMS for medical device industry
Haveitmade Companies in Cooperation with QUOIUM
Creating a core QMS for Guiding global organization to better awareness of quality and established awareness for starting MDR conformity in development.
Bis heute 6 Jahre und 3 Monate, seit Feb. 2018
Architect Supplier Management NPI 4, Lead SQE Mechatronic Robot arms
ASMLBis heute 7 Jahre, seit Mai 2017
Supplier Audits and improvement Follow up
Haveitmade Companies
Bis heute 15 Jahre, seit Mai 2009
Industrialization. Multi dusclipinairy, Complex, Medically regulated Business.
Haveitmade3 Jahre und 8 Monate, Juli 2017 - Feb. 2021
Auditor ISO13485 Re-certification and Unnanounced
DEKRA Certification GmbH
4 Monate, Sep. 2020 - Dez. 2020
Quality Assurance Manager
AQTIS a Sinclairpharma Company
4 Jahre, Dez. 2014 - Nov. 2018
Lead Auditor external auditor ISO 9001 and ISO 13485 20% time
Philips
Organize 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.
1 Jahr und 7 Monate, Juli 2016 - Jan. 2018
NPI & Supplier, business responsible medical consumer electronics 50% -> 70% / y
Philips GmbHSub business 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.. Design agreements and contracts. Setup working platform with Supplier for Collecting DHF/DMR APQP Approbation data and Capital spenditure for suppliers first Medical Device Class II ISO13485 portfolio production and compliant documentation.
2 Jahre und 10 Monate, Juni 2014 - März 2017
Medical Device Program and Project Management 30% to 10% last year
Philips Medical Consumer Electronics
Realizing cost down by New Product Introduction and Manufacturing Transfers of regulated medical product portfolio’s. Shape, expand and maintain New and existing markets. Effective Change Management clear impact analyses and business cases. Team up with corporate procurement and business stakeholders shaping Global supply base strategy. Gain trust, influence and build strong relationships in and outside the Business.
5 Jahre und 2 Monate, Dez. 2010 - Jan. 2016
Director Industrialization, Business and Product Development
Reliable LED
Responsible for industrialization and realization new projects mainly in China and Germany.
19 Jahre und 4 Monate, Okt. 1990 - Jan. 2010
Industrialization Teamleader
Océ a Canon company
2003-2007 Managing outsourcing to China as team leader and Malaysia as quality responsible In sourcing modules from contract manufacturing partner Czech republic to Netherlands Starting account responsibility Sanyo Japan continuation Arnold China and improvement project cleanroom Venlo. Same as 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.
Ausbildung von Johannes (Hans) van Leuven
Bis heute 9 Jahre und 11 Monate, seit Juni 2014
Lead-Auditor ISO13485 and ISO9001
Philips Academy.
Lead-Auditor medical ISO13485 and ISO9001 training and graduation . 2014-2017 Continuous learning by execution of Audits and follow up
Bis heute 9 Jahre und 11 Monate, seit Juni 2014
ISO13485 QMS medical devices verification, validation and certification
Philips University
30 trainings on regulated Consumer lifestyle and Medical industry.
1990 - 2010
Engineering Management related trainings
Various institutes
Training onCoaching and self-reflection courses, six sigma, lean trainings, strategic suppliers selection. During 2000 Manufacturing Excellence program by KPMG, a Lean on the job, training program. Technical and strategic sourcing trainings many technical fields
5 Jahre und 1 Monat, Aug. 1984 - Aug. 1989
Industrialization and design of fine mechanics
Fontys University of Applied Sciences
Realization Computer aided Manufacturing from 3D design
Sprachen
Englisch
Fließend
Niederländisch
Muttersprache
Deutsch
Gut
Französisch
Grundlagen
Italienisch
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Chinesisch
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