Karla T Email
Sr. Manager Quality Systems - CSS @ Johnson & Johnson MedTech
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Karla T Location
- Ladera Ranch, CA, US
Karla T Work
- 2022 -now Sr. Manager Quality Systems - CSS @
- 2019 -2022 Compliance Manager @
- 2017 -2018 Independent Consultant and Auditor @ Independent
- 2014 -2017 Compliance Manager @
- 2013 -2014 Manufacturing Manager @
- 2012 -2013 Process Excellence Manager @
- 2008 -2012 Engineering Manager (Cardio Products) @
- 2007 -2007 Project Leader (Transfers) @
- 2005 -2007 Industrial Engineer – Process Champion @
- 2003 -2005 Manufacturing Engineer @
Karla T Education
- BSI
ISO 13485:2003 Lead Auditor certified by BSI
2014 - Instituto Tecnológico y de Estudios Superiores de Monterrey, Campus Ciudad Juárez
Bachelor of Science in Industrial and Systems Engineering
2001 - J&J
Master Black Belt
2001 - CALISO
ISO 13485:2016
- AAMI
QSR 820 - training
- ASQ
CQA (Certified Quality Auditor by ASQ)
2010 - BSI Training Academy
Implementation of Medical Device Regulation for CE Marking Training Course
Karla T Skills
- Quality Management
- Kaizen Leadership
- Gemba
- GxP
- FDA GMP
- Validation Protocol
- Computer System Validation
- Product Lifecycle Management
- Internal Audits
- Failure Mode and Effects Analysis (FMEA)
- Certified Lead Auditor
- ISO 13485
- Project Management
- Training
- Problem Solving
- People Management
- Trend Analysis
- QSR
- Production Planning
- Lean Processes
- ISO Standards
- Corrective Actions
- Six Sigma
- Quality System
- DMAIC
- Corrective and Preventive Action (CAPA)
- Lean Manufacturing
- Validation
- 5S
- GMP
- Kaizen
- Manufacturing Engineering
- Manufacturing
- Management
- Engineering
- Engineering Management
- Medical Devices
Karla T Summary
- Karla T, based in Ladera Ranch, CA, US, is currently a Sr. Manager Quality Systems - CSS at Biosense Webster. Karla T brings experience from previous roles at Biosense Webster, Independent and Ethicon Endo-Surgery, Inc.. Karla T holds a ISO 13485:2003 Lead Auditor certified by BSI @ BSI . With a robust skill set that includes Quality Management, Kaizen Leadership, Gemba, GxP, FDA GMP and more. Karla T has 3 emails on RocketReach.
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