Stefan Klein Location
- Bavaria, Germany
Stefan Klein Work
- 2015 -now Owner @ Stefan Klein, SK-Medtech Solutions
- 2017 -now Lead Auditor @
- 2025 -now MDR Site Auditor, MDR Product Reviewer @
- 2020 -2024 Director QM and RA @
- 2019 -2020 Director QM and RA @
- 2019 -2019 Head of Quality Management and Regulatory Affairs @ ARRI MEDICAL GmbH
- 2016 -2019 Head of Quality Management and Regulatory Affairs @ Arnold & Richter Cine Technik GmbH & Co. Betriebs KG - ARRI Medical
- 2013 -2016 Manager, Quality Management and Compliance @
- 2012 -2013 Director Quality @ First Sensor AG
- 2012 -2013 VP Quality and Compliance @ Sensortechnics Corp.
- 2012 -2013 VP Quality and Compliance @ Sensortechnics Inc.
- 2011 -2012 Director Quality and Compliance @ Sensortechnics GmbH
- 2008 -2011 Head of Quality Department @ Sensortechnics GmbH
- 2006 -2008 Quality Engineer Europe @
- 2001 -2006 Coordinator Technical Service Europe @
Stefan Klein Education
- Hochschule München
Dipl. Ing (Medical Device Engineering)
1997-2001
Stefan Klein Skills
- Six Sigma
- Quality Management
- Design Control
- 21 CFR
- Supply Management
- Lean Manufacturing
- ISO 14971
- Cross Functional Team
- Supplier Evaluation
- GMP
- ISO
- Regulatory
- Electronics
- Change Control
- Supplier Quality
- FMEA
- Regulatory Affairs
- Iso 9000
- Validation
- Engineering
- Strategic Planning
- Medical Devices
- Quality Assurance
- Environmental Management Systems
- Sales Management
- Quality System
- V&V
- Testing
- New Business Development
- Quality Auditing
- ISO 14001
- Cross Functional Team Leadership
- Design of Experiments
- Manufacturing
- CE marking
- Environmental
- CQE
- Semiconductors
- Product Development
- Project Management
- Quality Control
- SPC
- Process Engineering
- Continuous Improvement
- CAPA
- FDA
- R&d
- Sop
- 21 CFR Part 11
- Automation
- CQA
- ISO 13485
- Internal Audit
Stefan Klein Summary
- Stefan Klein, based in Bavaria, Germany, is currently a Owner at Stefan Klein, SK-Medtech Solutions. Stefan Klein brings experience from previous roles at DQS Medizinprodukte GmbH, QMD Services, Munich Surgical Imaging GmbH and ARRI Medical GmbH. Stefan Klein holds a 1997 - 2001 Dipl. Ing in Medical Device Engineering @ Hochschule München. With a robust skill set that includes Six Sigma, Quality Management, Design Control, 21 CFR, Supply Management and more. Stefan Klein has 2 emails on RocketReach.
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Stefan Klein
Head Of Fixed Income
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