Jean Schikora - ISO 27001 Implementation

Q: Where is Jean based?

Jean is based in Burg (bei Magdeburg), Germany .

Q: What languages does Jean speak?

Jean speaks the following languages: German (Advanced), English (Intermediate) .

Q: How many years of experience does Jean have?

Jean has at least 22 years of experience. During this time, Jean has worked in at least 13 different roles and for 15 different companies . The average length of individual experience is 1 year and 3 months . Note that Jean may not have shared all experience and actually has more experience.

Q: What is Jean's latest experience?

Jean's most recent position is ISO 27001 Implementation at Software Developer .

Q: What companies has Jean worked for in recent years?

In recent years, Jean has worked for Software Developer , Transmission System Operator (Electricity Expansion) , Class I Medical Device Manufacturer (Robotic) , Class IIa Medical Device Manufacturer (Acoustics) , and Telecommunications Industry (Broadband Expansion) .

Q: Which industries is Jean most experienced in?

Jean is most experienced in industries like Manufacturing , Healthcare , and Automotive . Jean also has some experience in Energy , Utility Services , and Telecommunication .

Q: Which business areas is Jean most experienced in?

Jean is most experienced in business areas like Quality Assurance (QA) , Operations , and Strategy and Planning . Jean also has some experience in Project Management , Research and Development (R&D) , and Supply Chain Management .

Q: Which industries has Jean worked in recently?

Jean has recently worked in industries like Healthcare , Manufacturing , and Automotive .

Q: Which business areas has Jean worked in recently?

Jean has recently worked in business areas like Quality Assurance (QA) , Operations , and Strategy and Planning .

Recommended expert

Burg (bei Magdeburg), Germany

Experience

Aug 2024 - Jan 2025

6 months

ISO 27001 Implementation

Software Developer

Implemented an information security system within the existing ISO 9001 management system

May 2023 - Present

2 years 11 months

Quality Manager (PMO)

Transmission System Operator (Electricity Expansion)

Defined, coordinated, and supported quality management / quality assurance processes and measures in the overall project
Further developed the management system
Defined requirements, audited and monitored QM/QS measures of key contractors
Organized, conducted and followed up on Lessons Learned workshops
Handled complaint management

Aug 2022 - Mar 2023

8 months

ISO 9001 Implementation

Software Developer

Implemented a quality management system according to ISO 9001

Aug 2022 - Feb 2023

7 months

Interim Quality Manager

Class I Medical Device Manufacturer (Robotic)

Maintained and further developed the ISO 13485 quality management system
Processed CAPA
Supported audits with the notified body
Responsible person
Reviewed technical documentation
Served as Regulatory Affairs Manager
Qualified, developed, and audited suppliers

Jul 2022 - Sep 2022

3 months

Interim Quality Manager

Class IIa Medical Device Manufacturer (Acoustics)

Supported addressing findings after the initial MDR certification
Handled technical documentation

Nov 2021 - Jun 2024

2 years 8 months

Integrated Management Representative (Interim)

Telecommunications Industry (Broadband Expansion)

Restructuring of organizational structure and processes
Further development of management system for ISO 9001/ISO 14001/EMAS/Occupational Safety seal 'Safe with System'
Coaching in project, complaint and risk management
Process development
Operational support for complaints, test planning, supplier qualification/development, audit support
Quality, occupational safety and environmental management representative

Nov 2021 - Dec 2022

1 year 2 months

Interim Quality Manager

Class IIa Medical Device Manufacturer (Dental)

CAPA coordinator/complaint management according to ISO 13485 and GMP requirements
Risk management/FMEA team
Document/change management
Software validation
Supplier development

Apr 2021 - Sep 2021

6 months

ISO 9001 Implementation

Electronics Manufacturer

Establishment of a management system according to ISO 9001

Nov 2020 - Mar 2022

1 year 5 months

Interim Quality Manager

High-Performance Ceramics Manufacturer

Complaint management/risk analysis/FMEA facilitator
Maintenance of the management system according to ISO 9001
Test planning
Supplier qualification/development
GAP analysis IATF 16949
Onboarding of the quality management lead

May 2020 - Dec 2020

8 months

Strategic Process Development

Marketing & Web Group

Development of business processes
Definition of communication channels
Documentation management
Coaching in project management

Mar 2020 - Present

6 years 1 month

Strategic and Operational Management Consulting

Management Support - Jean Schikora

Strategic and operational management consulting for the automotive, medical device and industrial sectors

Mar 2020 - Dec 2024

4 years 10 months

Interim Quality Manager

Class IIa Medical Device Manufacturer (Software)

Created technical documentation using Confluence
Set up quality management system according to ISO 13485 using Confluence
Supported medical device approval
Guided transition from Class I (MDD) to Class IIa (MDR)
Managed complaint/change management using JIRA
Responsible person
Conducted clinical evaluation
Created/maintained medical device file
Regulatory Affairs Manager
Supported medical device decommissioning

Mar 2020 - Mar 2021

1 year 1 month

Project Management

Engineering Office (IT)

PMO
Developed project plans
Coordinated project tasks
Supported technical documentation

Mar 2017 - Aug 2019

2 years 6 months

Head of Quality Assurance/Quality Management

Wind Generator Manufacturing GmbH

Assessed and improved quality performance
Improved the ISO 9001 management system
Quality planning
International supplier qualification/development/auditing
Complaint management
Conducted and supported internal and external audits
FMEA moderator
Main responsibility for technical documentation worldwide

Jun 2015 - Feb 2017

1 year 9 months

Work and Travel

Jan 2013 - May 2015

2 years 5 months

Head of Quality Assurance/Quality Engineer

KmB Technologie Gesellschaft für rationelle Fertigung mbH

Enforcing and further developing the quality, environmental and energy management systems
Quality planning
Complaint management
Supplier qualification, development and auditing
FMEA moderator
Conducting and supporting internal and external audits
Preparing first sample inspection reports
Implementing and monitoring the continuous improvement process
Quality, energy, environmental, product safety, REACH and customer representative
Reviewing and approving technical documentation

Jul 2006 - Dec 2012

6 years 6 months

Quality Assurance Associate

KmB Technologie Gesellschaft für rationelle Fertigung mbH

Creating and maintaining quality documents
Complaint management
Preparing for quality, supplier and customer audits
Supplier selection, evaluation and sampling
Participating in the continuous improvement process
Preparing first sample inspection reports
Environmental and REACH representative
Maintaining the integrated management system
Reviewing technical documentation

Aug 2003 - Jun 2006

2 years 11 months

Industrial Clerk Trainee

KmB Technologie Gesellschaft für rationelle Fertigung mbH

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Manufacturing (20 years), Healthcare (6 years), Automotive (6 years), Energy (5.5 years), Utilities (3 years), and Telecommunication (2.5 years).

Manufacturing

Healthcare

Automotive

Energy

Utilities

Telecommunication

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (17.5 years), Operations (6 years), Strategy (6 years), Project Management (5.5 years), Research and Development (5 years), and Procurement (3.5 years).

Quality Assurance

Operations

Strategy

Project Management

Research and Development

Procurement

Skills

Standards: Iso 9000ff, Iso 13485, Iso 14971, Iatf 16949, Iso 14001, Iso 50001, Ifs
Methods: 8d Report, Capa, Apqp, Fmea, Ishikawa, 5 Whys, Ppap / Vda Samples
It Skills: Microsoft Office
Quality Stats: Capability Analyses
Sap, Sage
Smartsolve, Babtec, Qmswrapper, Think Project, Signavio
Jira, Confluence
Teamhood, Miro

Languages

German

Advanced

English

Intermediate

Education

Jan 2009 - Nov 2015

Hamburg Distance University, Leipzig Study Center

Bachelor of Engineering · Industrial Engineering, focus on Mechanical Engineering / Quality Management · Leipzig, Germany

Aug 2003 - Jun 2006

KmB Technology Company for Rational Manufacturing mbH, Zerbst

Training as an Industrial Clerk · Zerbst, Germany

Certifications & licenses

ISO 14001 Advanced Training for Environmental Management Representatives and Internal Auditors

VOREST AG

ISO 50001 Energy Management Representative

VOREST AG

ISO/IEC 27001:2022 Process Orientation and the 24 Controls

DQS GmbH

NIS2 at the Intersection with ISO 27001

DQS GmbH

ISO 13485 Internal Auditor

VOREST AG

Automotive Quality Management Representative

VOREST AG

ISO 14001 Internal Auditor / Environmental Site Auditor - EMAS

VOREST AG

VDA 6.5 Product Auditor

VOREST AG

VDA 6.3 Process Auditor

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, a subsidiary of Lübeck University of Applied Sciences

Automotive Methods - Core Tools for System/Process Auditors

VOREST AG

Biostatistics

Oncampus, a subsidiary of Lübeck University of Applied Sciences

Six Sigma

Oncampus, a subsidiary of Lübeck University of Applied Sciences

Expert Quality Management Medical Devices International TÜV

TÜV Rheinland

IATF 16949 Internal Auditor and Supplier Auditor

VOREST AG

Clinical Evaluation

Johner Institut

Data Protection Officer

VOREST AG

TÜV Quality Auditor

TÜV Rheinland

TÜV Quality Manager

TÜV Rheinland

TÜV Quality Representative

TÜV Rheinland

Healthy Leadership: How You and Your Team Stay Motivated and Perform at Your Best

Haufe Akademie Berlin

FMEA Training

TÜV Süd, Hanover

Lean Workshop Shopfloor Management

REFA, Barleben

Professional Problem Solving with the 8-D Method

VOREST AG, Aurich

Automotive Product Safety Officer

TÜV Akademie, Dresden

DGQ Quality Specialist

DGQ, Berlin

Basics of Form and Positional Tolerances

Perschmann, Braunschweig

Profile

Created

July 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Jean based?

Jean is based in Burg (bei Magdeburg), Germany.

What languages does Jean speak?

Jean speaks the following languages: German (Advanced), English (Intermediate).

How many years of experience does Jean have?

Jean has at least 22 years of experience. During this time, Jean has worked in at least 13 different roles and for 15 different companies. The average length of individual experience is 1 year and 3 months. Note that Jean may not have shared all experience and actually has more experience.

What roles would Jean be best suited for?

Based on recent experience, Jean would be well-suited for roles such as: ISO 27001 Implementation, Quality Manager (PMO), ISO 9001 Implementation.

What is Jean's latest experience?

Jean's most recent position is ISO 27001 Implementation at Software Developer.

What companies has Jean worked for in recent years?

In recent years, Jean has worked for Software Developer, Transmission System Operator (Electricity Expansion), Class I Medical Device Manufacturer (Robotic), Class IIa Medical Device Manufacturer (Acoustics), and Telecommunications Industry (Broadband Expansion).

Which industries is Jean most experienced in?

Jean is most experienced in industries like Manufacturing, Healthcare, and Automotive. Jean also has some experience in Energy, Utility Services, and Telecommunication.

Which business areas is Jean most experienced in?

Jean is most experienced in business areas like Quality Assurance (QA), Operations, and Strategy and Planning. Jean also has some experience in Project Management, Research and Development (R&D), and Supply Chain Management.

Which industries has Jean worked in recently?

Jean has recently worked in industries like Healthcare, Manufacturing, and Automotive.

Which business areas has Jean worked in recently?

Jean has recently worked in business areas like Quality Assurance (QA), Operations, and Strategy and Planning.

What is Jean's education?

Jean holds a Bachelor in Industrial Engineering, focus on Mechanical Engineering / Quality Management from Hamburg Distance University, Leipzig Study Center.

Does Jean have any certificates?

Jean has 29 certificates. Among them, these include: ISO 14001 Advanced Training for Environmental Management Representatives and Internal Auditors, ISO 50001 Energy Management Representative, and ISO/IEC 27001:2022 Process Orientation and the 24 Controls.

What is the availability of Jean?

Jean is immediately available for suitable projects.

What is the rate of Jean?

Jean's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.