Stefan Trampler

Angestellt, Vice President Regulatory Affairs, Quality Assurance & Design Assurance, Nobel Biocare

Germany, Deutschland

Fähigkeiten und Kenntnisse

Regulatory Affairs
Quality Management
Product Registration / Approval
Medical Device Directive (MDD) 93/42/EC
ISO 13485
FDA
QSR
Complaint & CAPA Management
DBS
SAP
GMP
ERP
CRM
Business Warehouse
Kaizen
Project Management
Continuous Improvement
Technical Controlling
Strength of Character
Focused on the Success of the Team
High Level of Motivation and Comprehension
Flexibility
Widespread Knowledge
Analytic Thinking
Medical Devices
Softwareentwicklung
ISO
Regulierung
International
Verantwortungsbewusstsein
QMS
ISO 9000

Werdegang

Berufserfahrung von Stefan Trampler

  • Bis heute 2 Jahre und 4 Monate, seit Feb. 2022

    Vice President Regulatory Affairs, Quality Assurance & Design Assurance

    Nobel Biocare

  • 2 Jahre und 1 Monat, Jan. 2020 - Jan. 2022

    Vice President Regulatory Affairs & Quality Assurance

    Envista Holdings Corporation

  • 2 Jahre und 8 Monate, Mai 2017 - Dez. 2019

    Sr. Director Regulatory Affairs & Design Assurance

    KaVo Kerr / Envista Holdings Corporation

  • 3 Jahre und 4 Monate, Jan. 2014 - Apr. 2017

    Director of Regulatory Affairs

    KaVo Kerr / Danaher Corp.

    Responsibility to establish and maintain a Quality Management System according to ISO 13485, QSR & Medical Device Directive 93/42/EC including the conventional Quality Management, the international Product Registrations (Approbation) and the standardization. Development of a standard for international Product Registrations for Medical Devices for different OPCO’s.

  • 4 Jahre und 2 Monate, Nov. 2009 - Dez. 2013

    Head of Quality Management & Regulatory Affairs

    KaVo Dental GmbH / Danaher Corp.

    Responsibility to establish and maintain a Quality Management System according to ISO 13485, QSR & Medical Device Directive 93/42/EC including the conventional Quality Management, the international Product Registrations (Approbation) and the standardization. Development of a standard for international Product Registrations for Medical Devices.

  • 3 Jahre und 7 Monate, Apr. 2006 - Okt. 2009

    Technical Controller

    KaVo Dental GmbH / Danaher Corp.

    Quality Improvements in the area of Medical Devices (Dentistry). Implementation of ISO 13485 and FDA requirements in the Dental Industry. Development and maintenance of a Complaint & CAPA Management System. Medical Device Reporting for Dental Instruments, Treatment Units and Dental High Tech Products.

Ausbildung von Stefan Trampler

  • 4 Jahre und 7 Monate, Sep. 2001 - März 2006

    Electrical Engineering, Information Engineering

    University of Applied Sciences (Zwickau)

    Hardware, Software, Embedded Systems, Computer Architecture, Communications Engineering, Circuit Board Design, ASIC-Design, Data Highway, Digital Signal Processing, Micro Processors, Hardware Oriented Programming, Digital Signal Processors

Sprachen

  • Deutsch

    -

  • Englisch

    -

Interessen

Business
Management
Finance
Sports
Friends

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