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Scott Eden Location
Austin, TX, US
Scott Eden Work
Sr. Director Manufacturing Engineering @ (December 2025 - Present)
Director of Manufacturing Engineering @ (December 2025 - August 2026)
Managing Partner @ (October 2024 - November 2025)
Director of Manufacturing @ (September 2022 - October 2024)
Chief Operating Officer (COO) @ (June 2018 - July 2019)
Global Director of Manufacturing Operations @ (July 2019 - September 2022)
Director of Manufacturing Operations @ Varian / Siemens Healthineers (June 2019 - September 2022)
Chief Operating Officer @ (June 2018 - June 2019)
Vice President Operations @ (June 2013 - June 2018)
Senior Director Quality and Regulatory @ (July 2010 - June 2013)
Senior Director Quality @ HealthTronics, Inc. Altaris Capital / Endo Pharmaceuticals Plc (July 2010 - June 2013)
Senior Director Quality @ Senior Director, Quality & Regulatory (July 2010 - June 2013)
Director, CAPA and Supplier Quality Management Systems @ (August 2008 - July 2010)
Quality Assurance Specialist @ Zimmer Inc. (January 2008 - January 2010)
Group Manager Quality Systems @ (April 2007 - August 2008)
Quality System Manager @ (April 2007 - August 2008)
Compliance Group Manager @ (January 2000 - April 2007)
Scott Eden Education
Northwestern University - Kellogg School of Management
Executive Management Program – Executive Scholar (Operations Management and Supervision)
2008-2013
Texas Tech University 1990-1995
Texas Tech University
Bachelor of Arts (PSYCHOLOGY)
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 Osteal Therapeutics, EdenTree Medical Device Consultants, Sirtex Medical Limited and Endocare, Inc.. Scott Eden holds a 2008 - 2013 Executive Management Program – Executive Scholar in Operations Management and Supervision @ 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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