Profilbild von Christian Schumann Geschäftsführer / Inhaber aus Merlischachen

Christian Schumann

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Letztes Update: 06.09.2022

Geschäftsführer / Inhaber

Firma: INGENIEURDIENSTLEISTUNG Christian Schumann GmbH
Abschluss: Diplomingenieur (FH) Maschinenbau - Fachrichtung Konstruktion und Entwicklung
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse)

Dateianlagen

curriculum_vitae_2020.docx

Skills

Projektmanagement,Medical Devices,ISO 13485:2016,Prozess Validierung,Risikomanagement,Riskmanager,QMS,Good Manufacturing Practice,CAPA,GDP,Technisches Produktmanagement,Technische Beratung,Microsoft Office,Microsoft Visio,Gage R&R,SAP R/3,3D CAD,GMP Compliance,Management,Lieferantenaudits,Audit interne,ISO 14971,GMP,DMS, MDR

Projekthistorie

03/2020 - 08/2020
Global Sourcing Manager - injection moulding
Medela AG (1000-5000 Mitarbeiter)
Pharma und Medizintechnik
Responsible for injection moulding suppliers. Communication with suppliers. Project lead of transfer projects. Support with MDR topics in purchasing department.

09/2019 - 02/2020
Projektleiter im Bereich Healthcare
Medela AG (1000-5000 Mitarbeiter)
Pharma und Medizintechnik

Project lead for product supplier move. Coordinating and building up a team with 6 persons. Communication and coordination with supplier overseas. Fulfilling regulatory (MDR) and internal requirements for product documentation during move.


01/2018 - 10/2019
Lead Auditor
Stryker (1000-5000 Mitarbeiter)
Pharma und Medizintechnik

Execution of Risk-based supplier audits according EN ISO 13485.

Identification of observations and findings and closure of relating NC records

Train and educate suppliers on regulatory requirements and Stryker expectations


04/2015 - 09/2015
Senior Supplier Quality Engineer / Lead Auditor
Zimmer Biomet GmbH (500-1000 Mitarbeiter)
Pharma und Medizintechnik

Review and Remediation of Process Validation Documents

GMP, GDP, CE conformity

21 CFR 820, ISO 13485, Desktop Audit execution

Support in execution of validations for special processes at different suppliers. Execution of supplier audits according ISO 13485 and 21CFR820

CAPA lead training (supplier validation related)


01/2014 - 03/2015
Projektleiter, Team Leader Validation Group
Johnson & Johnson, Depuy Synthes (5000-10.000 Mitarbeiter)
Pharma und Medizintechnik

Coordination of remediation according to 21 CFR 820 / ISO 13485

Process validation (IQ, OQ, PQ)

GMP, GDP, CE conformity

Project management and team leading (32 team members)

CAPA responsibility (project related, validation)

Reporting to upper project management


06/2013 - 12/2013
Senior Validation Engineer
Johnson & Johnson, Depuy Synthes (5000-10.000 Mitarbeiter)
Pharma und Medizintechnik

Review according to 21 CFR 820 and ISO 13485

Process validation (IQ, OQ, PQ)

Review of test and verification activities in accordance with process validation and equipment validations

GMP, GDP, CE conformity

Reisebereitschaft

Verfügbar in den Ländern Deutschland, Österreich und Schweiz

Kontaktformular

Kontaktinformationen

Profilbild von Christian Schumann Geschäftsführer / Inhaber aus Merlischachen Geschäftsführer / Inhaber
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