As a consultant for quality management and information security, I support you in the analysis and optimization of your processes! With almost 30 years of practical experience, I work with you as a team player. I pay attention to strategy, goals, comprehensibility, meaning, consistency and transparency.


I support you and your company professionally, in a variety of ways with responsibility and holistically:


For your Coworkers: e.g.: coaching, introducing methods, processes, guidelines, work instructions and knowledge building


Developing methods: e.g.: requirements engineering, error analysis, risk analysis, FMEA, measurement capability analysis, verification & validation, test methods, equipment qualification, installation qualification (IQ), functional qualification (operational qualification, OQ) performance qualification (performance qualification, PQ)


On your documentation: e.g.: product documentation, process documentation, consistency check, traceability, gap analysis


On your processes: Procedural instructions, work instructions, checklists, protocols, reports, evidence, training,


On your products and services: taking care about them over the entire life cycle


I use frameworks and international standards, GMP, GDP, COBIT, ITIL, PRINCE, CMMI etc.


We can conduct internal Audit together:

This shows whether everything and everyone worked together efficiently and effectively

Everything interlocks here, is your management system effective? From development to production, working with your partners, to achieve customer satisfaction and improve your company and your products.

My idea of cooperation:

Reliability

People

Responsibility

Sustainability

Integrity

Discretion

Qualification / Training

Qualification / training (excerpt)
2022 - IT security - technical implementation
2022 - Appointment as auditor for information security by Dekra Certification GmbH
2021 – EU Medical Device Regulation MDR 2017/745
2021 - EU In-vitro-Diagnostika IVDR 2017/746
2021 – Risk Management ISO 14971:2019
2021 – Medical Device Single Audit Program MDSAP
2020 – ISO 9001:2015 Quality Management, repeat audit
2020 – ISO 14001:2015: Environmental Management
2017 - ISO 27.001: Certification as an internal auditor according to IRCA for information security management systems
2016 - FDA 21 CFR Part 820: Continuing education requirements of the US Food and Drugs Administration for medical devices
2016 - ISO 14971: Advanced training in risk management in general and specifically for medical devices
2016 - EN ISO 13485: Certification as an internal auditor and supplier auditor for quality management systems for medical devices
2014 - ISO 9001 / ISO 19011: Certification as internal auditor for quality management systems
2009 – ITIL: Expert Certificate in IT Service Management APM Group (ITIL® v3)
2009 – ITIL: Manager's Certificate in IT Service Management EXIN (ITIL® v2 Service Manager)
2008 - PRINCE2: PROJECT MANAGEMENT Foundation certification
1998 – 2007 Specialist training as an employed consultant
1988 – 1993 – Dipl. Ing. (FH) Studies in biotechnology: FH WEIHENSTEPHAN / FREISING
1984 – 1988 - Studies in biology: LUDWIG MAXIMILIANS UNIVERSITY, MUNICH

On the way to quality management and information security


  • Studied biology / biotechnology, degree in biotechnology engineer - University of Applied Sciences Weihenstephan / Freising
  • Medical product consultant for medical aids.
  • Consultant for digitization, using digital archives, document management and electronic content management (ECM).
  • Since 2007 independent consultant for process optimization, transition and service management for IT organizations and IT departments across all industries.
  • Since 2011 independent consultant in quality management, also for manufacturers of medical products and large laboratory equipment
  • Advice on requirements management
  • Since 2020 cooperation with DECURA quiub GmbH - manufacturer of digital certification systems
  • Cooperation with DEKRA Certification GmbH since 2021


Excerpt - projects

Roche Diagnostics Automation Solutions GmbH, Stuttgart Kornwesthei: Pre-analysis systems

Requirements Engineering, IVDR Gap Closure, Technische Dokumentation

Validation of test methods, analysis of measuring equipment capability

Definition and optimization of processes in business service management

Technolas Perfect Vision, Munich: LASIK eye surgery

Requirements Engineering, Test Management, Verification & Validation, Technical Documentation

Implementation of the European directive for medical devices "Restriction of hazardous Substances RoHS-2 2011/65/EU

Roche Diagnostics Automation Sunlutions GmbH, Stuttgart Kornwesthei: Pre-analysis systems

Requirements Engineering, Gap Closure, Technische Dokumentation

FARO Europe, Korntal-Münchingen near Stuttgart: 3D laser scanner

Test management and test development



Technolas Perfect Vision, Munich: Cataract eye surgery

Requirements Engineering, Test Management, Verification & Validation, Technical Documentation

Siemens Enterprise Communications, München: IT Services

Carve Out / Koordination Client Rollout

Definition and optimization of IT processes, gap closure

Data World Consulting AG, Schwisscom, Swiss Federal Railways SBB, Bern CH: IT Services

Integration of a document management system into business processes and IT service management

Siemens AG Munich, IT Services

Audit preparation ISO 9001, ISO 27.001

Service Transition one worldwide compliance management systems

Data World Consulting AG, Bern CH: IT Services

Development of the service catalogue

IXOS GmbH / OpenText Corporation

Digital archiving of data and information, electronic content management systems.

Training, support, concepts, advice

You want to get in contact with me? Very gladly!

  • Every person and every company has its strengths and weaknesses. It is important to recognize both and to deal with them objectively, to absorb weaknesses and to use strengths.
  • It's always with each other, not against each other!
  • I bring theoretical know-how to every project and the experience from all previous projects.
  • Every project needs a red thread that everyone can orientate themselves towards.
  • Every project needs an overview of countless details, a consistency check.
  • Every manager and auditor needs a well-founded overview, always up-to-date, always reliable.
  • We all learn together, constantly, throughout life.
  • We learn from our mistakes, and from the mistakes of others.
  • We learn from what we do well, and what others do well.
  • I learned all I know from others friendly people, so I like to give my knowledge to others!
  • Let's go the next steps together!
Share by: