Friederike Balaz - Information Security Manager

Recommended expert

Schwäbisch Gmünd, Germany

Experience

Feb 2023 - Apr 2023

3 months

Information Security Manager

Johner Medical GmbH

Nov 2017 - Aug 2019

1 year 10 months

Quality Manager and IT Security Officer

DST it-services GmbH

Setup, implementation and certification of an ISMS according to ISO 27001 (2019-01-01)
Maintaining the ISMS and extending it to another sister company

Aug 2017 - Present

8 years 6 months

Freelance IT and management systems consultant

Self-employed

Strategy and regulatory affairs consulting for a medical device (stand-alone software) (2023-11-01 – present)
SQL/SSRS reporting project (2023-08-01 – present)
KRITIS audit – traffic and transport (2023-06-01)
KRITIS audit – traffic and transport (2023-03-01)
ISMS completeness audit according to §8a(1) BSIG (KRITIS) (2022-08-01)
Setup of quality management and risk management system for a medical device (stand-alone software) (2022-05-01 – 2023-06-30)
IT project management, consulting and implementation of Taifun industry software, electrical engineering (2022-04-01 – 2023-04-30)
IT project management, implementation & administration of CRM Streit V.1 (2020-06-01 – 2023-01-31)
Support in the founding and certification of a company and bringing a new medical device (stand-alone software) to market (2019-12-01 – 2020-12-31)
Consulting and implementation of GDPR requirements and information security basics (2019-05-01 – 2019-12-31)

Nov 2015 - May 2017

1 year 7 months

Vice President Professional Service

Qonsilus GmbH

Technical and disciplinary management of the service, support and operations areas
Customer projects (implementation & customization) and training
Ensuring operations (SaaS)
Coordination of all update and service tasks
Risk management officer for all medical devices at Qonsilus GmbH
Maintenance of the QMS for professional service and risk management
Administration of the CRM system (Steps.IT) and the QWare Risk Manager

Jun 2014 - Nov 2015

1 year 6 months

Head of Application Development

Qonsilus GmbH

Technical and disciplinary management of application development, support and IT areas
Scrum Product Owner
Development and documentation of company processes

Dec 2012 - Jun 2014

1 year 7 months

Application Analyst / Product Owner

Siemens Industry Software GmbH

Scrum Product Owner
Creating customer requirements
Ensuring compliance with quality gates
Developing and documenting company processes
Training internal employees
Localizing software products

Feb 2011 - Dec 2012

1 year 11 months

User Support / Quality Assurance

Perfect Costing Solutions GmbH

Developing and documenting company processes
Training internal employees on all in-house software products and workflows
Executive assistant tasks
Coordinating and monitoring software tests and test coverage
Administering Steps Business Solution (Step Ahead), ERP systems, and ticket/service management systems
Preparing data for import into SAP
Creating SQL views for data analysis
Maintaining automated forecast generation
Localizing software products
User support for Perfect ProCalc and Perfect CalCard
Supporting the internal IT team
Software testing and error reproduction
Creating user documentation and training materials
Internal training on the ERP system and customer training for Perfect ProCalc
Maintaining the ticket/service management system

Jun 2007 - Dec 2010

3 years 7 months

User Help Desk Specialist

Saint Gobain ISOVER G+H AG

First-level support for all PC users
Second-level support for application software
Installing PCs and peripherals
User administration and support
Administering all hardware and software
Installing software on PCs, notebooks, and thin clients
Installing printers and replacing faulty hardware
Creating training materials
Managing the terminal server farm (Citrix)
Maintaining ticket, change, and asset management
Project management (Novell server migration, software packaging, Active Directory migration)
Generating reports in Crystal Reports
Communicating with ISPs, suppliers, and external service providers

Sep 2004 - Jun 2007

2 years 10 months

IT System Administrator / PC Coordinator

TRW Automotive GmbH

Training apprentice IT specialists (system integration)
Coordinating external service providers
Procuring hardware, software, and consulting services
Supporting SAP R/3
Requesting quotes and making purchasing decisions
Budgeting
Providing support for all PC users
Installing PCs, notebooks, thin clients, and tablet PCs
User administration and support
Administering all hardware and software
Server and web server administration (Windows/Novell/Windows 2003 Server)
Maintaining the intranet and replacing faulty hardware
Communicating with suppliers
Project management (CARM server, UiB)

Mar 2003 - Jun 2003

4 months

Internship Abroad - Internet Service Provider

Tasman Solution

Creating a landing page for Tasman Solution clients

Nov 2000 - Aug 2001

10 months

Intern in the Information Systems Department

Festo AG & Co.

Supported the migration to Windows 2000 clients (notebooks and desktops)
Created migration plans
Installed software on PC clients
Scheduled and managed rollout teams
Prepared reports and presentations on the migration
Tested and documented notebook dial-up to the Internet via mobile phone and infrared connection
Conducted training sessions, briefings, and coordinated the Windows 2000 migration teams

Skills

Very Good Knowledge Of Ms Office
Office 365
Microsoft System Administration
Project Management
Iso 27001
Iso 22301 Bcm
Scrum Product Owner
Quality Management
Iso 13485
Risk Management
Iso 14971
Steps.it
Streit V.1
Organizational And Planning Skills
Business Process Reengineering
Ntc

Languages

German

Native

English

Advanced

French

Elementary

Education

Apr 2022 - Present

University for Continuing Education Krems / Johner Institute

Master of Science Regulatory Affairs Management · Regulatory Affairs Management · Krems an der Donau, Austria

Sep 2001 - Sep 2004

Heidenheim University of Cooperative Education

Diploma in Business Informatics (BA), Bachelor of Arts (2nd division), focus on eCommerce / eBusiness · Business Informatics eCommerce / eBusiness · Heidenheim, Germany · 2,6

Aug 1997 - Jun 2000

Technical High School

Subject-specific university entrance qualification · Schwäbisch Gmünd, Germany

...and 1 more

Certifications & licenses

Additional audit procedure competence for § 8a (3) BSIG

ISACA Germany Chapter e.V.

ISO/IEC 27001 Practitioner – Information Security Officer (APMG)

Maxpert GmbH

Lead Auditor ISO 22301:2012

BSI Group

Risk management and risk analysis for medical devices according to DIN EN ISO 14971

Johner Institut GmbH

Qware Risk Manager user training

bayoonet AG

Risk management and risk analysis for medical devices according to DIN EN ISO 14971:2012

TÜV SÜD Akademie GmbH

CSPO - Certified Scrum Product Owner

Scrum Alliance

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Björn Bausch

Experience

Information Security Manager

Johner Medical GmbH

Quality Manager and IT Security Officer

DST it-services GmbH

Freelance IT and management systems consultant

Self-employed

Vice President Professional Service

Qonsilus GmbH

Head of Application Development

Qonsilus GmbH

Application Analyst / Product Owner

Siemens Industry Software GmbH

User Support / Quality Assurance

Perfect Costing Solutions GmbH

User Help Desk Specialist

Saint Gobain ISOVER G+H AG

IT System Administrator / PC Coordinator

TRW Automotive GmbH

Internship Abroad - Internet Service Provider

Tasman Solution

Intern in the Information Systems Department

Festo AG & Co.

Skills

Languages

Education

University for Continuing Education Krems / Johner Institute

Master of Science Regulatory Affairs Management · Regulatory Affairs Management · Krems an der Donau, Austria

Heidenheim University of Cooperative Education

Diploma in Business Informatics (BA), Bachelor of Arts (2nd division), focus on eCommerce / eBusiness · Business Informatics eCommerce / eBusiness · Heidenheim, Germany · 2,6

Technical High School

Subject-specific university entrance qualification · Schwäbisch Gmünd, Germany

Certifications & licenses

Additional audit procedure competence for § 8a (3) BSIG

ISACA Germany Chapter e.V.

ISO/IEC 27001 Practitioner – Information Security Officer (APMG)

Maxpert GmbH

Lead Auditor ISO 22301:2012

BSI Group

Risk management and risk analysis for medical devices according to DIN EN ISO 14971

Johner Institut GmbH

Qware Risk Manager user training

bayoonet AG

Risk management and risk analysis for medical devices according to DIN EN ISO 14971:2012

TÜV SÜD Akademie GmbH

CSPO - Certified Scrum Product Owner

Scrum Alliance

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