Mathias T. Eng

Inhaber, Founder & CEO, QUAREGIA GmbH

Kestenholz, Schweiz

Fähigkeiten und Kenntnisse

cGxP environment (medical devices
combination products
IVD's): Product Development Process
Project Management
Quality Management
Risk Management
Change Management
Requirements Engineering & Management
Configuration Management
Usability Engineering
Software Engineering
V&V
Post Market Surveilance
Complaint Handling
CAPA Management
Design Controls
Technical Documentation
Technical Files
Design History Files
Document Controls
Process Validation
Computer System Validation
Waste Management Concepts
Regulatory Affairs Services
Registration Dossiers
Premarket Submissions
Premarket Submissions for Software Contained in Me
FDA-483 - Warning Letter Response. Regulations & S
FDA 21CFR Part 820
FDA 21CFR Part 11
MDD 93/42/EEC
Richtlinie 2007/47/EG
AIMDD 90/385/EEC
IVDD 98/79/EC
Richtlinie 2011/65/EU (RoHS)
Richtlinie 2002/96/EG (WEEE)
ISO 9001
ISO 14001
ISO 90003
ISO 13485
ISO 14971
IEC 80002
ISO 11608-X
IEC 62304
IEC 62366
IEC 60601-1
GMP
GEP
GAMP4
GAMP5
PIC/S
GHTF
STED
AHWP
CSDT. Special interests: Agile Development Process
Scrum

Werdegang

Berufserfahrung von Mathias T. Eng

  • Bis heute 5 Jahre und 3 Monate, seit März 2019

    Founder & CEO

    PROREGIA AG

  • Bis heute 5 Jahre und 4 Monate, seit Feb. 2019

    Founder & CEO

    QUAREGIA GmbH

  • Bis heute 12 Jahre und 5 Monate, seit 2012

    Dozententätigkeit

    ARIAQ

    "Manager qualité et en affaires réglementaires pour dispositifs médicaux". Lectures in module 13: “Software validation for medical devices”

  • Bis heute 17 Jahre und 5 Monate, seit 2007

    Dozententätigkeit

    Bern University of Applied Sciences

    Lectures and accompanies certifications of thesis at the University of Applied Sciences in Bern, Switzerland. Master of Advanced Studies in Medical Technology Management and Medical Informatics Management • product development according to ISO13485 • software lifecycle process acc. to IEC 62304 • process validation • computer system validation acc. to GAMP5 • application of risk management to medical devices according to ISO 14971 • requirements management and engineering

  • 9 Jahre und 1 Monat, 2010 - Jan. 2019

    Key Account Manager - Partner

    confinis ag

    Key account manager for clients in the medical device, pharmaceutical, biotechnology and diagnostic industries.

  • 11 Jahre und 1 Monat, Jan. 2008 - Jan. 2019

    Senior Consultant - Partner

    confinis ag

    Providing professional services to the pharmaceutical, biotechnology, medical device, and diagnostic industries (incl. combination products)

  • 3 Jahre, Jan. 2005 - Dez. 2007

    Project Manager

    CSA Engineering AG

    overall responsibility for configuration and requirements management for the development of dialysis machines; project leader for the development of test equipment for medical devices; implementation and training of quality management systems compliant with ISO 13485.

  • 4 Jahre und 5 Monate, Aug. 2001 - Dez. 2005

    Software Engineer

    CSA Engineering AG

    development of embedded software for a power supply unit; development of a real-time application framework for MSP430 derivatives which is successfully used in several products; member of the IT-Services Team at CSA for 4 years, the last 2 years of which as project manager

Ausbildung von Mathias T. Eng

  • 2001 - 2003

    University of Applied Sciences, Zuerich

  • 1997 - 2000

    University of Applied Sciences, Lucerne

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Muttersprache

  • Französisch

    Grundlagen

Interessen

Hiking
jogging
travelling
nature
agile development processes
scrum
planning and building photovoltaic systems and controllers for photovoltaic systems

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