Friederike Balaz
Information Security Manager
Experience
Information Security Manager
Johner Medical GmbH
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
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)
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
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
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
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
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
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)
Internship Abroad - Internet Service Provider
Tasman Solution
- Creating a landing page for Tasman Solution clients
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
Industry Experience
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Experienced in Information Technology, Healthcare, Transportation, Construction, Automotive, and Manufacturing.
Business Area Experience
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Experienced in Information Technology, Project Management, Quality Assurance, Customer Service, Product Development, and Procurement.
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
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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