Jean Schikora-Introduction to ISO 27001
Check rate
Experience
Introduction to ISO 27001
Software developer
- Introduction of an information security management system into an existing management system according to ISO 9001
Quality Manager (PMO)
Transmission system operator (electricity expansion)
- Definition, coordination and support of QM/QS processes and measures in the overall project
- Further development of the management system
- Definition of requirements, auditing and monitoring of QM/QS measures of key contractors
- Organization, execution and follow-up of lessons learned workshops
- Complaint handling
Introduction to ISO 9001
Software developer
- Introduction of a QM system according to ISO 9001
Interim Quality Manager
Medical device manufacturer class I (robotics)
- Maintenance and further development of QM system ISO 13485
- CAPA handling
- Audit support for notified body
- Responsible person
- Review of technical documentation
- Regulatory affairs manager
- Supplier qualification/development/auditing
Interim Quality Manager
Medical device manufacturer class IIa (acoustics)
- Support in closing findings after the first MDR certification
- Handling of technical documentation
Integrated management representative (interim)
Telecommunications industry (broadband expansion)
- Restructuring of organizational structure and workflows
- Further development of management system ISO 9001/ISO 14001/EMAS/Occupational safety seal Safety with System
- Coaching in project, complaint and risk management
- Process development
- Operational support with complaints, test planning, supplier qualification/development, audit support
- Quality, occupational safety and environmental management representative
Interim Quality Manager
Medical device manufacturer Class IIa (dental)
- CAPA coordinator/complaint management in line with ISO 13485 and GMP requirements
- Risk management/FMEA team
- Document/change management
- Software validation
- Supplier development
Introduction of ISO 9001
Electronics manufacturer
- Set up management system in line with ISO 9001
Interim Quality Manager
High-performance ceramic producer
- Complaint management/risk analysis/FMEA facilitator
- Maintenance of management system in line with ISO 9001
- Test planning
- Supplier qualification/development
- GAP analysis IATF 16949
- Training of quality management lead
Strategic process development
Marketing & web company group
- Development of business processes
- Definition of communication channels
- Documentation management
- Coaching in project management
Strategic and Operational Management Consulting
Management Support - Jean Schikora
- Strategic and operational management consulting for the automotive, medical device, and industrial sectors
Interim Quality Manager
Medical device manufacturer class IIa (software)
- Creation of technical documentation with Confluence
- Setup of quality management system according to ISO 13485 with Confluence
- Support for medical device approval
- Support during conversion from class I (MDD) to class IIa (MDR)
- Management of complaint/change management with JIRA
- Responsible person
- Carrying out clinical evaluation
- Creation/maintenance of the medical device file
- Regulatory Affairs Manager
- Support for decommissioning of medical device
Project Management
Engineering office (IT)
- PMO
- Preparation of project plans
- Coordination of project tasks
- Support with technical documentation
Head of Quality Assurance/Quality Management
Wind generator manufacturing GmbH
- Assessment and further development of quality performance
- Further development of the ISO 9001 management system
- Quality planning
- International supplier qualification/development/auditing
- Complaint management
- Carrying out and supporting internal and external audits
- FMEA moderator
- Main responsibility for technical documentation worldwide
Work and Travel
Work and Travel
Head of Quality Assurance/Quality Engineer
KmB Technologie Gesellschaft für rationelle Fertigung mbH
- Enforcement and further development of the quality, environmental, and energy management system
- Quality planning in advance
- Complaints management
- Supplier qualification/development/auditing
- FMEA moderator
- Carrying out and supporting internal and external audits
- Creating initial sample inspection reports
- Carrying out and monitoring the continuous improvement process
- Quality, energy, environmental, product safety, REACH, and customer representative
- Reviewing and approving technical documentation
Quality Assurance Employee
KmB Technologie Gesellschaft für rationelle Fertigung mbH
- Creating and maintaining quality documents
- Complaints management
- Preparing quality, supplier, and customer audits
- Supplier selection/evaluation, sampling
- Supporting the continuous improvement process
- Creating initial sample inspection reports
- Environmental and REACH representative
- Maintaining the integrated management system
- Reviewing technical documentation
Industrial Clerk Apprentice
KmB Technologie Gesellschaft für rationelle Fertigung mbH
Industry Experience
See where this freelancer has spent most of their professional time.
Experienced in Manufacturing, Healthcare, Automotive, Energy, Utilities, and Telecommunication.
Business Area Experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Operations, Strategy, Project Management, Research and Development, and Procurement.
Skills
- Standards: Iso 9000ff, Iso 13485, Iso 14971, Iatf 16949, Iso 14001, Iso 50001, Ifs
- Methods: 8d Report, Capa, Apqp, Fmea, Ishikawa, 5 Why, Ppap/Vda Sample Approvals
- It Skills: Microsoft Office
- Qa Stats: Capability Analyses
- Sap, Sage
- Smartsolve, Babtec, Qmswrapper, Think Project, Signavio
- Jira, Confluence
- Teamhood, Miro
Languages
Education
Hamburger Fernhochschule, Leipzig study center
Bachelor of Engineering · Industrial engineering, focus on mechanical engineering/quality management · Leipzig, Germany
KmB Technologie Gesellschaft für rationelle Fertigung mbH, Zerbst
Training as an industrial clerk · Zerbst, Germany
Certifications & licenses
Advanced training for environmental management representatives and internal auditors ISO 14001
VOREST AG
Energy management officer ISO 50001
VOREST AG
ISO/IEC 27001:2022 process orientation and the 24 controls
DQS GmbH
NIS2 at the intersection with ISO 27001
DQS GmbH
Internal Auditor ISO13485
VOREST AG
Internal Auditor/Environmental Management Auditor ISO14001 - EMAS
VOREST AG
Product Auditor VDA 6.5
VOREST AG
VOREST AG
Responsible Person According To Art. 15 Regulation (EU) 2017/745
Trautmann Managementsystem GmbH & Co. KG
Medical Writing
Apollon Hochschule
Introduction to Medical Technology
Oncampus, subsidiary of the University of Applied Sciences Lübeck
Automotive Methods - Core Tools for System/Process Auditors
VOREST AG
Biostatistics
Oncampus, subsidiary of the University of Applied Sciences Lübeck
Six Sigma
Oncampus, subsidiary of the University of Applied Sciences Lübeck
Expert Quality Management Medical Devices International TÜV
TÜV, Rheinland
Clinical Evaluation
Johner Institut
VOREST AG
TÜV, Rheinland
Quality Manager TÜV
TÜV, Rheinland
TÜV, Rheinland
Leading Healthily: How to Stay Motivated and High-Performing, Together With Your Team
Haufe Akademie Berlin
FMEA training
TÜV Süd, Hannover
Lean workshop shopfloor management
REFA, Barleben
Professional Problem Solving with the 8D Method
VOREST AG, Aurich
Product Safety Officer Automotive
TÜV Akademie, Dresden
DGQ quality specialist
DGQ, Berlin
Basics of form and position tolerances
Perschmann, Braunschweig
Statistics
Experience
Expertise
Qualifications
Profile
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