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Scott Eden Location
Austin, TX, US
Scott Eden Work
2025 -now Sr. Director Manufacturing Engineering @
2024 -2025 Managing Partner @
2022 -2024 Director of Manufacturing @
2019 -2022 Global Director of Manufacturing Operations @
2018 -2019 Chief Operating Officer (COO) @
2013 -2018 Vice President Operations @
2010 -2013 Senior Director Quality and Regulatory @
2008 -2010 Director, CAPA and Supplier Quality Management Systems @
2007 -2008 Group Manager Quality Systems @
2000 -2007 Compliance Group Manager @
Scott Eden Education
Northwestern University - Kellogg School of Management
Executive Scholar (General Management)
2008-2013
Texas Tech University 1990-1995
Scott Eden Skills
ISO 13485
CAPA
Quality System
Medical Devices
Quality Assurance
FDA
CE marking
Supplier Quality
Design Control
Hardware Diagnostics
Validation
Sop
Biomedical Engineering
GMP
Leadership
Manufacturing
Biotechnology
Regulatory Affairs
Regulatory Submissions
SPC
GxP
Pharmaceutical Industry
Quality Auditing
ISO 14971
21 CFR
Process Improvement
V&V
Root Cause Analysis
Product Launch
FMEA
Quality Management
PMA
Technology Transfer
Six Sigma
R&D
ISO
Manufacturing Operations
FDA GMP
DMAIC
Cross-functional Team Leadership
Commercialization
CQA
21 CFR Part 11
Contract Manufacturing
Regulatory
Corrective and Preventive Action Capa
Cross Functional Team Leadership
Design of Experiments
u.s. Food and Drug Administration Fda
Financial Analysis
Quality Control
Corrective and Preventive Action
u.s. Food and Drug Administration
Scott Eden Summary
Scott Eden, based in Austin, TX, US, is currently a Sr. Director Manufacturing Engineering at Osteal Therapeutics. Scott Eden brings experience from previous roles at EdenTree Medical Device Consultants, Sirtex Medical Limited, Varian Medical Systems and Endocare, Inc.. Scott Eden holds a 2008 - 2013 Executive Scholar in General Management @ Northwestern University - Kellogg School of Management. With a robust skill set that includes ISO 13485, CAPA, Quality System, Medical Devices, Quality Assurance and more. Scott Eden has 3 emails and 2 mobile phone numbers on RocketReach.
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