Tore Winge Kot Email & Phone Number | Highly experienced in designing and maintaining quality management systems. Worked on multiple operational effectiveness and process improvement projects such as digitization of a paper-based quality management system, implementation of an ERP system, competence training management, packaging and labeling management. I have many years of experience in implementing IT projects: - SharePoint for document management and collaboration - Jeeves enterprise resource planning (ERP) system - CANEA One a document, case and process management system. - Computer System risk management, validation and maintenance of the CANEA IT system ----Know-how---- Quality Management Computer System Validation Corrective action and preventative action process Deviation process CAPA management Complaint management Change management Process Risk Management Management Review Supplier control Process improvement Artwork and Labelling management Document management Database & Information management Competence (training) management Sharepoint design and admin Jeeves ERP design and admin CANE One design and admin Jira Software, Jira Core and Jira Service design and admin Life Science Medical Device ISO 13485 Medical Device Directive 93/42/EEC , MDD 2007/47/EC 21 CFR 820 Part 11 MDD Annex II GMP GAMP 5 ISO/TR 80002-2:2017 Validation of software for medical device quality systems Regulatory market access and registrations Compliance Market analysis ----Digital Tools know-how---- Sharepoint Administrator Sharepoint Design Jeeves enterprise resource planning system (ERP) design Adobe Photoshop, Adobe Illustrator, Adobe Indesign BarTender Zebra Software (label creation software) SPSS CANEA One Jira Software, Jira Core, Jira Service Management Arena Solutions eQMS ---Interests--- Health technologies, SaMD software as medical device, IEC 62304, UX, agile, interactive design, digital health, public health, sports and music

Tore Winge Kot

Highly experienced in designing and maintaining quality management systems. Worked on multiple oper...
Stockholm, Stockholm County, Sweden

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Tore Winge Kot’s Email tore.winge@bactiguard.se

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Tore Winge Kot’s Location Stockholm, Stockholm County, Sweden

Tore Winge Kot’s Current Industry Raysearch Laboratories

Tore Winge Kot’s Prior Industry Nuvoair | Bactiguard | Vadestra | P | Science Business

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Work Experience

Raysearch Laboratories

Quality Assurance & Regulatory Affairs Specialist

2023-09-01 00:00:00 - Present

Nuvoair

Senior Quality Assurance Officer

2020-06-01 00:00:00 - 2023-06-01 00:00:00

Bactiguard

Quality Assurance Officer

2011-05-01 00:00:00 - 2020-06-01 00:00:00

Vadestra

Junior analyst

2010-11-01 00:00:00 - 2011-03-01 00:00:00

P

Freelance translator and editor for PwC

2010-05-01 00:00:00 - 2010-08-01 00:00:00

Science Business

Health for All, Care for You. The challenges of personalised healthcare in Europe

2010-04-01 00:00:00 - 2010-04-01 00:00:00

Skills

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FAQ About Tore Winge Kot

Tore Winge Kot is located at
Stockholm, Stockholm County, Sweden

Tore Winge Kot is a Highly experienced in designing and maintaining quality management systems. Worked on multiple operational effectiveness and process improvement projects such as digitization of a paper-based quality management system, implementation of an ERP system, competence training management, packaging and labeling management. I have many years of experience in implementing IT projects: - SharePoint for document management and collaboration - Jeeves enterprise resource planning (ERP) system - CANEA One a document, case and process management system. - Computer System risk management, validation and maintenance of the CANEA IT system ----Know-how---- Quality Management Computer System Validation Corrective action and preventative action process Deviation process CAPA management Complaint management Change management Process Risk Management Management Review Supplier control Process improvement Artwork and Labelling management Document management Database & Information management Competence (training) management Sharepoint design and admin Jeeves ERP design and admin CANE One design and admin Jira Software, Jira Core and Jira Service design and admin Life Science Medical Device ISO 13485 Medical Device Directive 93/42/EEC , MDD 2007/47/EC 21 CFR 820 Part 11 MDD Annex II GMP GAMP 5 ISO/TR 80002-2:2017 Validation of software for medical device quality systems Regulatory market access and registrations Compliance Market analysis ----Digital Tools know-how---- Sharepoint Administrator Sharepoint Design Jeeves enterprise resource planning system (ERP) design Adobe Photoshop, Adobe Illustrator, Adobe Indesign BarTender Zebra Software (label creation software) SPSS CANEA One Jira Software, Jira Core, Jira Service Management Arena Solutions eQMS ---Interests--- Health technologies, SaMD software as medical device, IEC 62304, UX, agile, interactive design, digital health, public health, sports and music