Hans Schnater Email & Phone Number

's-Hertogenbosch, NB, NL

Consultant and Auditor (ISO9001, ISO13485 / 21CFR820, 21CFR4 and ISO17025) support, by using more then 25 years of experience in the Product and System Quality (and Regulatory) international world, to help organizations showing the added values of a good Quality System, being able (by GAP-analysis through assessment) finding bottlenecks.

Houten, Utrecht, NL

Finalized the GAP analysis for the upcoming CE/ISO13485 and MDSAP - recertification Audit and given recommendations towards its compliancy level.

Washington, DC, US

Currently appointed as Senior QA/RA Expert to support a global company to become EU MDR compliant to keep sell their Medical Devices in Europe.

Somerset, New Jersey, US

Supporting the QA/RA manager in driving Quality & Regulatory compliance while aligning with the overall organization to meet business Needs & Objectives. Maintaining Technical dossiers for all Quirem products, Monitoring regulatory developments and assessing business impact. Leading/supporting initiatives to improve the quality and manufacturing efficacy.

Marseille, Provence-Alpes-Cote d'Azur, FR

To support CEVA specifically in its services regarding "Medical Devices" as being the Economic Operator as defined by the MDR (Medical Device Regulations) as being ratified per 27 May, 2021. Additional to support its continuous good relationship with customer Philips.

Eindhoven, Brabant, NL

Assure continuity of all Project activities (e.g. MDR, UDI) during absence of current project Lead.

Berlin, DE

Supporting the Company with its Class III Medical Device NanoTherm AS1 as Regulatory Assurance Manager ad interim. Tasks: MDR implementation, Certification readiness and Technical File generation for a changed System.

Münchenstein, CH

Supporting a Bio-chemical Manufacturer in updating the Risk Management Process and Filings including MDR activities and Review of Technical Files for submission purposes.

Waterloo, ON, CA

Leading the QA, Reliability and RA Team at TeledyneDalsa Professional Imaging. Assurred re-certification by sufficient coordination of (limited) staff in june 2018; closed Major Non-conformities and planned sufficient closure of Minors. Started MDR implementation to assure readiness for 05-2020, Initiated additional QA & RA staff needed.

Albstadt, Baden-Württemberg, DE

Support a Medical Device manufacturer in the FDA QA & RA Remediation project to continue Compliance, improve its Quality Management System and establish sensible processes.

London, GB

Conducting a GAP Analysis to give guidance in the remediation as planned to be done with internal staff.

Irvine, CA, US

Project-lead for the Implementation of an ISO13485 & GMP compliant QA/QMS for Edwards Lifesciences new distribution-center in Switzerland, location Spreitenbach.

Baarle-Nassau, Nordbrabant, NL

First GAP analysis for upcoming Audit.

Basel, Baselstadt, CH

Hired by NOVARTIS to support the new 2015 defined Biologics Technical Development and Manufacturing (BTDM) Department in the creation of a new/improved LifeCycle Management (LCM) process during both Development and Commercialization of the many end-products as (to be) marketed. Upgrading/implementing the 21CFR parts 4 and 820, and the ISO13485:2016.

Warsaw, Indiana, US

Hired as Subject Matter Expert for support for the current/local Remediation Project of this location. Main activities are; giving input and reviewing the final/current Remediated DHF's (Design History Files) and TF's (Technical Files) assuring compliance to all product (and processes used) Regulations being applicable for Powertools and deratives as being.

Zwijnaarde, Gent, BE

Executive responsibility of both the Quality Assurance and Regulatory Affairs of the company. Goals & Objective were: 1)Setting up the strategy and establishment of all Quality and Regulatory related disciplines for both the Processes and Products, 2)Plan & Planning in improvement activities, assuring compliance to all applicable regulations, including no.

Warsaw, Indiana, US

April 2014 - presentHired by Zimmer GmbH in Switzerland as CAPA Subject Matter Expert for the Site/location Winterthur, supporting CAPA owners in various working areas following its applicable CAPA system (including remediation as/if required).

New Brunswick, NJ, US

Hired by J&J, being Senior Subject Matter Expert, in this case for the CAPA process for the Site/location Waldenburg "Power Tools & Cases". Assuring full compliance meeting global regulations. Improving its current processes as implemented by DuPuy, now also becoming Johnson & Johnson's responsibility since the acquisition of DuPuy Synthes last year..

Hired as Project Manager QMS/Senior Consultant for short-time Quality Engineering Interim function.

Eindhoven, Noord Brabant, NL

Hired as Director Quality Assurance & Regulatory Affairs for the new Philips Health & Light Venture Business. Main responsibility in establishing a QMS compliant to ISO13485:2003, ultimately succeeding the becoming the CE Certificates for both the System AND the PRODUCT via DEKRA!Also Quality Project Leader and Safety & Compliance Manager.

Wayne, PA, US

Hired as Project Manager QMS/Senior Consultant for short-time Quality Engineering Interim function.

Veenendaal, Utrecht, NL

Being hired as Senior QA Consultant, Advisor and Auditor to assure implementation of a full compliant Quality System under ISO13485 for MDD/AIMD (CE) Certificate

Puteaux, FR

Responsible Quality Assurance & Regulatory Assurance for the location VITAL SCIENTIFIC BV at Dieren/The Netherlands. Vital is one of the partners under the ELITechGroup, for which I have the Quality Assurance responsibility for the whole Group. Also see www.elitechgroup.com

Amsterdam, Noord-Holland, NL

I was responsible for Quality, Regulatory and Sustainability ot the Business Unit X-Ray, (1.6BEuro in 2006), with underlaying 4 Businesslines and 16 Factories worldwide (USA, Brazil, Europe (Netherlands/Germany/Italy), Asia/China PR (Shenyang).Total reporting QA/RA+Sustainabilitygroup was apprx. 60 persons.

Chicago, US

Responsible for Quality System and Regulatory Compliance for Location Zeist (70 employees), software development for PACS systems. Also back-up for Germany sites (Dornstadt + Freiburg) and Wuxi/China PR.

Consultancy & Advisory Organization wrt Quality of Systems and Products. Specialized in European and Asian Regulations for marketing products in both regions. Assessment of factories.

Certification Manager located in Hong Kong (headquarters KEMA HK, also responsible for 2 locations in Guangzhou and Shanghai/PR China). Biggest personal achievement was: upgraded the Quality System to regain its CBTL status again, training of staff, networking in China.

Assured compliance to all product's requirements Globally (e.g., UL60950, EN60950.) Upgraded the Certification processes for Europe from the pre-"CE"-age into the European "CE"-processes (ISO9000 series). BSI became the first "safety"-Notified Body for EU, as KEMA (now DEKRA) became the EMC certifier.Many visits to BSI and UL (for the UL-certifications as.

Amsterdam, NL

Starting my career here as Junior Electronic Engineer, also started my educations (evening/weekend) ultimately received my BSc's for both 3rd degree Teacher Electrical Techniques and 2nd degree Teacher Electronics & Information Technique. Then ultimately was promoted as Senior Electronic Technician. Gained many experience in building Electronic Systems for.

Master'S Degree, Total Quality Management

Internal Training/Workshop Iso14155

21Cfr820 + Iso13485

Master Of Business Administration (Mba), Organizational Leadership

Post Hbo Study Electro Magnetic Compatibility

Bachalor Of Science, Electronics + Information Technology

Certified Lead Auditor Iso9001

Certified Lead Auditor Iso13485:2016, Quality Management Systems - Medical Devices - 2014, Quality Management Systems - Medical Devices - 2014