Jean Schikora - ISO 27001 Implementation

Go to Website

Burg (bei Magdeburg), Germany

Experience

Aug 2024 - Jan 2025

6 months

Germany

ISO 27001 Implementation

Software Developer

Implemented an information security management system into an existing ISO 9001 management system

May 2023 - Present

2 years 3 months

Germany

Quality Manager (PMO)

Transmission Network Operator (Electricity Expansion)

Defined, coordinated, and supported quality management/quality assurance processes and measures in the overall project
Enhanced the management system
Defined requirements, audited, and monitored QM/QS measures of key contractors
Organized, conducted, and followed up on lessons learned workshops
Handled complaints

Aug 2022 - Mar 2023

8 months

Germany

ISO 9001 Implementation

Software Developer

Implemented a quality management system according to ISO 9001

Aug 2022 - Feb 2023

7 months

Germany

Interim Quality Manager

Class I Medical Device Manufacturer (Robotic)

Maintained and developed the QMS according to ISO 13485
Handled CAPA
Supported audits by the Notified Body
Responsible person
Reviewed technical documentation
Regulatory Affairs Manager
Supplier qualification, development, and auditing

Jul 2022 - Sep 2022

3 months

Germany

Interim Quality Manager

Class IIa Medical Device Manufacturer (Acoustics)

Supported addressing findings after MDR initial certification
Worked on technical documentation

Nov 2021 - Jun 2024

2 years 8 months

Germany

Integrated Management Representative (Interim)

Telecommunications Industry (Broadband Expansion)

Restructured organizational and process workflows
Further developed the management system ISO 9001/ISO 14001/EMAS/Occupational Health and Safety 'Safe with System' seal
Coached in project, complaint, and risk management
Developed processes
Provided operational support for complaints, test planning, supplier qualification/development, and audit support
Quality, occupational safety, and environmental management representative

Nov 2021 - Dec 2022

1 year 2 months

Germany

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 and change management
Software validation
Supplier development

Apr 2021 - Sep 2021

6 months

Germany

ISO 9001 Implementation

Electronics Manufacturer

Built a management system according to ISO 9001

Nov 2020 - Mar 2022

1 year 5 months

Germany

Interim Quality Manager

High-Performance Ceramics Manufacturer

Complaint management/risk analysis/FMEA facilitator
Maintained the management system according to ISO 9001
Test planning
Supplier qualification and development
IATF 16949 gap analysis
Onboarding in QMS leadership

May 2020 - Dec 2020

8 months

Spain

Strategic Process Development

Marketing & Web Corporate Group

Developed business processes
Defined communication paths
Managed documentation
Coached project management

Mar 2020 - Present

5 years 5 months

Lorem ipsum dolor sit amet

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

Germany

Interim Quality Manager

Class IIa Medical Device Manufacturer (Software)

Created technical documentation using Confluence
Built a quality management system according to ISO 13485 with Confluence
Supported medical device approval
Assisted in transition from Class I (MDD) to Class IIa (MDR)
Managed complaint and change management with JIRA
Responsible person
Performed clinical evaluation
Prepared and maintained the medical device file
Regulatory Affairs Manager
Assisted in medical device decommissioning

Mar 2020 - Mar 2021

1 year 1 month

Germany

Project Management

Engineering Office (IT)

PMO
Developed project plans
Coordinated project tasks
Supported technical documentation

Mar 2017 - Aug 2019

2 years 6 months

Magdeburg, Germany

Head of Quality Assurance/Quality Management (Wind Energy)

Wind Turbine Manufacturing GmbH

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

Jun 2015 - Feb 2017

1 year 9 months

Australia

Work and Travel

Jan 2013 - May 2015

2 years 5 months

Zerbst, Germany

Head of Quality Assurance/Quality Engineer (Automotive)

KmB Technology Company for Rational Manufacturing mbH

Enforced and further developed the quality, environmental, and energy management systems
Quality planning
Complaint management
Supplier qualification, development, and auditing
FMEA facilitator
Conducted and supported internal and external audits
Prepared initial sample inspection reports
Conducted and monitored the continuous improvement process
Quality, energy, environmental, product safety, REACH, and customer representative
Reviewed and approved technical documentation