Viktor Leske

Angestellt, Regulatory Compliance Manager EU, Jabil Healthcare

Bettlach, Schweiz

Fähigkeiten und Kenntnisse

CAPA
Quality Systems
NCR
Blackbelt CAPA & NC
FDA SME
Six Sigma Green Belt
Process Validation
Data Analysis
Training & Coaching
8D-Systematik
Sample (PPAP)
Claimmanagement
APQP
Qualitätsmanagement
Qualität
Audit

Werdegang

Berufserfahrung von Viktor Leske

  • Bis heute 1 Jahr und 8 Monate, seit Nov. 2022

    Regulatory Compliance Manager EU

    Jabil Healthcare

  • Bis heute 3 Jahre und 4 Monate, seit März 2021

    Senior Regulatory Compliance Site Lead

    Jabil Healthcare

    Performing audits, representing POC for 2 sites in all regulatory compliance matters, Certified on ISO 13485, ensure audit readiness and act as SME.

  • 5 Jahre und 4 Monate, Nov. 2015 - Feb. 2021

    Quality System Analyst

    DePuy Synthes a Johnson & Johnson Company

    Management of CAPA-, NC-, Audit- and Complaint activities. Coaching and training users. Supporting and participating as responsible SME during audit activities. Data analysis and evaluation, reportings to management, site responsible for Dashboard Metric.

  • 2 Jahre und 6 Monate, Mai 2013 - Okt. 2015

    Quality Engineer

    Sinterwerke AG (ehm. Mahle Motorkomponenten Schweiz AG)

    Customer support for quality issues, supplier quality, samples (PPAP), production support by quality methods, control of quality during production, quality gates, metrology, workinstructions, training, audit, solving problems at customer and supplier, claim management, continuous improvement projects

  • 1 Jahr und 7 Monate, Okt. 2013 - Apr. 2015

    Consultant

    University of Furtwangen

    Establishment of project-master-files by using VBA (Excel) in order to improve internal process for administration of projects between University and Customers (companies). Creating dynamical PDF files as an improvement project (modified files with failure reduction by using POKA YOKE methods).

  • 1 Jahr und 3 Monate, März 2012 - Mai 2013

    Student Assistent

    Univeristy of Furtwangen

    Support for the optimization of internal processes of the university administration and university projects.

  • 9 Monate, Okt. 2011 - Juni 2012

    Tutor

    University of Furtwangen

    Tutor: subject electronic / electrical engineering for third semester

  • 6 Monate, März 2011 - Aug. 2011

    Internship in Quality Management

    Mahle Motorkomponenten Schweiz AG

    Projects in the quality management, fault cause analysis, fewer rejects, CIP through workshops, implementation of a quality circle.

  • 2 Jahre und 6 Monate, Okt. 2006 - März 2009

    Staff Soldier

    Bundeswehr

    Headquarters service soldier in the brigade headquarters of the German / French brigade, division human ressources - situation centre / personnel for overseas operations. Second job: standby unit for operations abroad

Ausbildung von Viktor Leske

  • 2009 - 2013

    Wirtschaftsingenieurwesen (Product Engineering)

    Furtwangen University of Applied Sciences

    Interdisciplinary study of science and economy

  • 3 Jahre und 1 Monat, Jan. 2003 - Jan. 2006

    Secondary School

    Richard-Fehrenbach-Gewerbeschule

    Engineering

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Russisch

    Grundlagen

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