Gerhard Steinberger

Quality Manager, Quality Management Consultant

Eckental, Germany
Experience
Aug 2023 - Present
2 years
Nuremberg, Germany

Team Leadership Technical Writing

ITZBund

  • Creating manuals and guides
  • Advising authors regarding the federal cloud portal
  • Researching and learning new features
  • Revising technical texts in the CMS Drupal
  • Reviewing technical texts in the CMS Drupal
  • Revising technical texts in Confluence
  • Reviewing technical texts in Confluence
  • Creating BPMN processes
  • Implementing corporate design/identity guidelines
  • Administering SharePoint and SIB-Box
  • Storing technical documents on various drives (SharePoint, SIB-Box, BSCW)
  • Leading team members functionally
Nov 2022 - Jul 2023
9 months
Karlsruhe, Germany

Quality Manager

Atruvia AG

  • Checking relevant documents professionally, technically, and stylistically
  • Image editing
  • Supporting internal audits
  • Implementing corporate design/identity guidelines
Jan 2022 - Jan 2023
1 year 1 month
Munich, Germany

Quality Manager

Carl Zeiss Meditec

  • Developing a quality management system for certification and approval of medical devices
  • Checking relevant documents for certification and customer certification audits
  • Creating and reviewing work instructions and SOPs
  • Planning and meeting requirements and milestones
  • Advising and managing technical documentation per ISO 13485, EN IEC 62366, etc. and MDR for certifying a software product as a medical device
  • Supporting external and internal audits, handling deviations (CAPAs)
  • Administering SharePoint
  • Creating and scaling document templates
  • Implementing corporate design/identity guidelines
  • Storing technical documents on various drives (SharePoint)
  • Supporting external and internal audits
  • Archiving files on the respective drives
Jun 2021 - Dec 2022
1 year 7 months
Vienna, Austria

SW Test Manager

Verbund

  • Conducting software tests for Vision/ADA and Quantum applications
  • Creating test cases and performing software tests
  • Supporting test automation
  • Test methods: equivalence classes, boundary value analysis
  • Manual software tests in embedded environments
Jun 2021 - Aug 2022
1 year 3 months

Technical Writer

Löwenstein Medical

  • Creating requirement specifications, concepts, and requirement documents for medical devices
  • Assisting in medical device validation (preparing documentation for the external audit)
  • Researching and learning new features
  • Creating technical documentation for medical devices
Apr 2021 - Jul 2021
4 months
Germany

Requirement Analyst & Writer

ITZ Bund

Assigned to Aperto IBM

  • Creating requirement specifications, requirement documents, architecture documents, operations manuals, architecture concepts, interpreting UML diagrams and converting them into text
Sep 2020 - Jul 2022
1 year 11 months
Leopoldsdorf im Marchfelde, Austria

Quality Manager

HSE365.AT

  • Developing a quality management system for certification and approval of medical devices
  • Creating relevant documents for certification and customer certification audits
  • Creating work instructions and SOPs
  • Planning and managing project resources and staff
  • Planning and meeting requirements and milestones
  • Creating training materials, moderating trainings
  • Developing technical documentation per ISO 13485, EN IEC 62366, and MDR for certifying a software product as a medical device
  • Supporting external and internal audits, handling deviations (CAPAs)
  • Administering SharePoint
  • Storing technical documents on various drives (SharePoint)
  • Supporting external and internal audits
  • Archiving files on the respective drives
  • Creating and scaling document templates
  • Implementing corporate design/identity guidelines
Sep 2019 - Jun 2021
1 year 10 months
Graz, Austria

Product Owner, Technical Writer, Document Manager

Black Tusk GmbH

Project transferred from Medifina GmbH to Black Tusk GmbH

  • Creating requirement specifications, concepts, and requirement documents for a document management tool
  • Creating product backlog items and features (agile project)
  • Planning and managing project resources and staff
  • Planning requirements and milestones
  • Moderating review and retro meetings
  • Planning development documents
  • Developing technical documentation per MDR and ISO 13485 for certifying a product as a medical device
  • Supporting external and internal audits
  • Administering SharePoint
  • Storing technical documents on various drives (SharePoint)
  • Supporting external and internal audits
  • Archiving files on the respective drives
Aug 2019 - Sep 2020
1 year 2 months
Erlangen, Germany

Consultant, Document Manager

Siemens Mobility GmbH

  • Discussing current state of documentation
  • Improving documentation processes
  • Planning requirements and milestones
  • Planning development documents
  • Coaching junior document manager
  • Creating process documentation
  • Storing technical documents in SAP EDM
Aug 2018 - Apr 2019
9 months

Technical Writer, Document Manager

Siemens AG

  • Revising post-sales manuals using the SIPS+ authoring system
  • Implementing a template to convert PDF manuals to HTML
  • Researching and learning new features
  • Managing manual translations
Jun 2018 - Aug 2019
1 year 3 months
Vienna, Austria

Product Owner, Technical Writer, Document Manager

Medifina GmbH

  • Creating requirement specifications, concepts, and requirement documents for a document management tool
  • Creating product backlog items and features (agile project)
  • Planning and managing project resources and staff
  • Planning requirements and milestones
  • Moderating review and retro meetings
  • Planning development documents
  • Developing technical documentation per MDR and ISO 13485 for certifying a product as a medical device
  • Supporting external and internal audits
Sep 2017 - Apr 2018
8 months

Release Manager/Coordinator, Rollout Manager

Bundesagentur für Arbeit

  • Creating scripts and presentations
  • Preparing interfaces
  • Coordinating major and minor releases and rollouts for BA
  • Implementing optimization measures
  • Creating and monitoring necessary changes
  • Commissioning software tests
  • Responsible for planning and managing ERP procedure releases and rollouts according to BA release management guidelines (process, timing, quality)
  • Planning, monitoring, and supporting process execution in the area of responsibility based on BA release management guidelines
  • Authorizing releases and rollouts
  • Signing off final implementation scope of releases
  • Scheduling releases and rollouts for current and following year
  • Internal coordination and publication
  • Supporting the test system coordinator in creating and aligning scripts for each environment
  • Supporting the test manager in commissioning all parties involved via Change
  • Providing rollout documents (test reports, release notes, scripts, etc.)
  • Quality assurance of process execution and first escalation instance
  • Ensuring overview of changes to the system landscape
  • If minimum quality requirements of a release are not met: coordinating decision-making for the release go-live
  • Approving releases for test, acceptance, and phase changes
  • Advising projects/products
  • Further developing SAP-related release coordination processes and technical support as well as tool use
  • Collaborating closely with BA ITIL process owners and coordinators
  • Early life support after program versions
  • Supervising the quality gate process for releases and rollouts
  • Processing issues in Solution Manager (SMP) using ChaRM (role: ChaRM Manager)
Aug 2014 - Dec 2015
1 year 5 months

Technical Writer

BMW AG

  • Creating online help, maintaining intranet pages
  • Administering SharePoint
  • Storing technical documents on various drives (SharePoint)
Apr 2014 - Aug 2015
1 year 5 months

Technical Writer

Siemens AG Industry Sector

  • Creating online help (manual) for an electronic catalog using SIPS+
  • Coordinating content with project management and development
  • Researching and learning new catalog features for online help
  • Managing manual translations
Jan 2014 - Jul 2017
3 years 7 months

SW Tester, 2nd Level Support, Technical Writer, BIBA Specialist

Bundesagentur für Arbeit

All in the same department

  • Creating online help, manuals, brochures for office communication
  • Preparing interfaces
  • Conducting software tests of BK software
  • Creating and coordinating change requests
  • Providing and configuring environments on Linux servers
  • Analyzing, identifying, diagnosing, and resolving software issues
  • Operating, monitoring, and supporting central office communication services and systems
  • Troubleshooting Windows client applications (BA standard workstation)
  • Troubleshooting office communication applications
  • Coordinating complex incident resolution processes
  • Involving other second- or third-level support units
  • Creating documentation, test concepts, scripts for service-oriented architecture (SOA)
  • Creating test cases and performing software tests
  • Supporting test automation and keyword notation
  • Test methods: equivalence classes, boundary value analysis
  • Implementing optimization measures
  • Providing user configuration support
  • Manual software tests in embedded environments
Oct 2013 - Jan 2014
4 months

SAP Basis Support Staff

Eckart GmbH

Assigned to Eckart GmbH via Hays AG

  • Assigning roles, permissions, and user accounts in SAP
  • General support tasks
Oct 2012 - Oct 2013
1 year 1 month

Technical Writer

Siemens AG Industry Sector

  • Creating online help (manual) for an electronic catalog using SIPS+
  • Coordinating content with project management and development
  • Researching and learning new catalog features for online help
  • Managing manual translations
Apr 2012 - Oct 2013
1 year 7 months

2nd Level Support & Trace Manager

Siemens AG Particle Therapy

Assigned to Siemens AG Particle Therapy via Serv.Fit GmbH

  • Supporting subsystem owners in requirement engineering, i.e., creating trace matrices, managing baselines (MedTrace/e-Trace, Caliber RM) for PT system development lines VA and VB
  • Supporting PT staff with PT tool issues, 2nd level support
  • Assigning roles, permissions, and user accounts (SAP, Caliber RM)
  • Ensuring tool functionalities needed for PT development process
  • Representing PT interests in cross-healthcare meetings (e.g., Tracing@Med, RM@Med, RM@CCB, ESC)
  • Maintaining process descriptions
  • Administering and supporting PLM tools (SAP, Caliber RM, MedTrace, eTrace, OutsideIn)
  • Training and advising on SAP EDM use/processes for PT staff, including intercultural teams
Jan 2010 - Dec 2012
3 years

Software Test Manager

Siemens AG Industry Sector

  • Coordinating/performing software tests for electronic product catalogs
  • Analyzing specifications/aligning with development and project management
  • Creating test cases (HP Quality Center)
  • Gathering and preparing test data
  • Conducting system tests
  • Logging test results/documenting errors
  • Re-testing fixed errors
  • Defining test cases and performing regression tests
  • Managing test environment (HP Quality Center)
  • Coordinating test activities including novice testers
  • Manual software tests in embedded environments
Jan 2009 - Dec 2012
4 years

Data Manager Quality Assurance

Siemens AG Industry Sector

  • Maintaining commercial product master data with PMD, Access, and SAP
  • Quality control in price lists and catalogs
  • Managing translation processes
Jan 2008 - Dec 2009
2 years

Data Manager Quality Assurance

Siemens AG Industry Sector

Assigned to Siemens AG Industry Sector via Mohles GmbH

  • Maintaining commercial product master data with PMD, Access, and SAP
  • Quality control in price lists and catalogs
  • Managing translation processes
Jan 2004 - Dec 2005
2 years

1st Level Support Document & Trace Manager

Siemens AG Healthcare CT

Assigned to Siemens AG Healthcare CT via HSZ GmbH

  • Supporting requirement engineering, i.e., creating trace matrices, managing baselines (MedTrace, Caliber RM) for CT scanners
  • Supporting CT staff with CT tool issues, 1st level support
  • Assigning roles, permissions, and user accounts (SAP, Caliber RM)
  • Creating documents and document plans (BOMs in SAP)
  • Maintaining process descriptions
  • Administering and supporting PLM tools (SAP, Caliber RM, MedTrace, OutsideIn)
  • Training and advising on SAP EDM use/processes for CT staff, including intercultural teams
Jan 2001 - Dec 2004
4 years

Interviewer

Conducting market research studies, product and service testing

Jan 2000 - Dec 2001
2 years

Clerk Outbound Logistics, Packaging, Customs

Siemens AG

  • Handling spare parts business
  • Customs declarations for goods in preferential and non-preferential trade
  • Intrastat reporting
Jan 1999 - Dec 2000
2 years

Working Student HR Support Center

Siemens AG

  • Supporting the introduction of the electronic personnel archive EPA in ARCIS by adding metadata to individual documents
  • Assisting in rebuilding the personnel data archive
  • Working on daily tasks in the HR department
Jan 1999 - Dec 1999
1 year

Working Student HR Support Center

Siemens AG

Assigned to Siemens AG via Technoservice GmbH

  • Supporting the introduction of the electronic personnel archive EPA in ARCIS by adding metadata to individual documents
  • Assisting in rebuilding the personnel data archive
  • Working on daily tasks in the HR department
Jan 1996 - Dec 1997
2 years

Logistics Clerk

JKD GmbH

  • Receiving goods
  • Packaging and shipping
  • Exchanging customer devices
Jan 1995 - Dec 1996
2 years

Clerk Agencies Special Audit

Quelle AG

Managing and closing Quelle agencies in the new federal states

Jan 1995 - Dec 1995
1 year

Intern

Marktkauf GmbH

General secretarial tasks

Jan 1993 - Dec 1995
3 years

Train Dispatcher

Deutsche Bahn AG

Setting routes for freight and passenger trains

1st Level Support Document & Trace Manager

Siemens AG Healthcare CT

Assigned to Siemens AG Healthcare CT via SYNG4 GmbH

  • Supporting requirement engineering, i.e., creating trace matrices, managing baselines (MedTrace, Caliber RM) for CT scanners
  • Supporting CT staff with CT tool issues, 1st level support
  • Assigning roles, permissions, and user accounts (SAP, Caliber RM)
  • Creating documents and document plans (BOMs in SAP)
  • Maintaining process descriptions
  • Administering and supporting PLM tools (SAP, Caliber RM, MedTrace, OutsideIn)
  • Training and advising on SAP EDM use/processes for CT staff, including intercultural teams
Summary
  • Test analysis chemistry, defense
  • Test management authorities, medical technology
  • Business analysis software development
  • Requirements engineering automotive, aerospace
  • Technical writing semiconductors, energy
  • Audit support
  • Processes medical technology (ISO 13485; IEC 62304; ISO 14971; MDD; MDR; etc.)
  • NATO AQAP
  • DIN EN ISO 9000
  • Accessibility
  • Plain language
Languages
German
Native
English
Advanced
French
Intermediate
Latin
Intermediate
Italian
Elementary
Education
Sep 1994 - Mar 1999

Fachhochschule Ingolstadt

Diplom-Betriebswirt (FH) · Business Administration · Ingolstadt, Germany

Sep 1991 - Jul 1994

Fachhochschule München

Industrial Engineering · Munich, Germany

Sep 1989 - Jun 1990

Fachoberschule Ingolstadt

Advanced Technical College Entrance Qualification · Ingolstadt, Germany

...and 1 more
Certifications & licenses

Contract Archive – Contract Processing and Archiving for the "ContractAdministrator" (V0)

ISTQB Certified Tester Foundation Level

MS Access 2003 Basics for Users

Microsoft Excel 2003 Advanced Techniques

Microsoft Excel 2003 Basics

Software Tests Certified Tester FL

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