2016 -2021 Quality and Regulatory Affairs Manager @
2013 -2016 Chef, Kvalitet - Quality Manager, Europe @ Temperature Sensitive Solutions AB
2005 -2013 Chef, Kvalitet and Regulatory - Director, Quality Design Assurance and Regulatory Submission @
1999 -2005 Chef, Projektkontor and Projektledning - Director, Product Development and System Engineering @
1992 -1999 Design Assurance Engineer and Manager @
Johan Sköld Education
Linköpings universitet
Master of Science (Computer Science)
1986-1991
Johan Sköld Skills
Leadership
Six Sigma
Quality Management
Design Control
Lean Manufacturing
ISO 14971
Public Speaking
Systems Engineering
Certified Program Manager
GMP
ISO
Business Development
Regulatory Affairs
Change Control
FMEA
International Relations
Team Leadership
Validation
Process Improvement
Medical Devices
Quality Assurance
Corrective And Preventive Action Capa
Regulatory Requirements
Quality System
Project Portfolio Management
Program Management
Risk Management
ISO 14001
Quality Auditing
Testing
Cross Functional Team Leadership
Document Management
Design of Experiments
Internal Communications
Marketing
JavaScript
U.S. Food And Drug Administration Fda
Failure Mode And Effects Analysis Fmea
FDA GMP
Design Assurance
Customer Service
Regulatory Submissions
Project Management
Product Development
ISO Standards
Continuous Improvement
CAPA
DMAIC
FDA
R&D
21 CFR Part 11
Process Simulation
ISO 13485
Photoshop
Engineering
u.s. Food and Drug Administration
Failure Mode and Effects Analysis
Corrective and Preventive Action
Johan Sköld Summary
Johan Sköld, based in Stockholm County, Sweden, is currently a Konsultchef QA and RA Medtech, Sr QA and RA Konsult at Prevas AB. Johan Sköld brings experience from previous roles at SDS MedteQ, MASIMO Sweden AB, Temperature Sensitive Solutions AB and St Jude Medical. Johan Sköld holds a 1986 - 1991 Master of Science in Computer Science @ Linköpings universitet. With a robust skill set that includes Leadership, Six Sigma, Quality Management, Design Control, Lean Manufacturing and more. Johan Sköld has 2 emails on RocketReach.
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