Jean Schikora - ISO 27001 Implementation

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 9 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

5 years 11 months

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

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