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!
