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James Stephens Location
Joshua, TX, US
James Stephens Work
2025 -now Sr Director Quality Ops @
2023 -2025 Director Of Quality Compliance @ Orthofix Ltd
2019 -2023 Director of Quality Ops and Design Control @
2017 -2018 Consultant Quality and Regulatory @
2015 -2016 Sr. Director Quality and Regulatory @
2005 -2015 Senior Corporate Director of Quality Systems @
2002 -2005 Senior Group Quality Manager @ Synthes Trauma
1998 -2002 QA Manager @
1997 -1998 Senior Quality Engineer @
1986 -1997 Process Quality Engineer @
1981 -1984 Communication Specialist @
James Stephens Education
Purdue University
Master's degree (Industrial Technology)
2000-2002
Dallas Baptist University
Bachelor of Applied Science (B.A.Sc.) (Business Administration and Management)
1992-1996
James Stephens Skills
Leadership
Six Sigma
Quality Management
Quality System Compliance
Auditing
Design Control
R
Supply Management
Lean Manufacturing
Supply Chain Optimization
ISO 14971
Manufacturing Engineering
Root Cause Analysis
GMP
ISO
Statistical Process Control Spc
Regulatory
Supply Chain Management
Regulatory Affairs
FMEA
Team Leadership
Validation
Process Improvement
Quality Assurance
Medical Devices
Corrective and Preventive Action Capa
Compliance
Quality System
V&V
Cross Functional Team Leadership
Manufacturing
Product Management
u.s. Food and Drug Administration Fda
FDA GMP
Regulatory Compliance
Regulatory Submissions
Business Process Improvement
Project Management
Product Development
Quality Control
ISO Standards
Continuous Improvement
Supply Chain
CAPA
FDA
21 CFR Part 11
Cost of Quality
ISO 13485
Statistical Process Control
u.s. Food and Drug Administration
Corrective and Preventive Action
James Stephens Summary
James Stephens, based in Joshua, TX, US, is currently a Sr Director Quality Ops at Argon Medical Devices, Inc.. James Stephens brings experience from previous roles at Orthofix Ltd, ZimVie Dental, MAETRICS and DJO Global. James Stephens holds a 2000 - 2002 Master's degree in Industrial Technology @ Purdue University. With a robust skill set that includes Leadership, Six Sigma, Quality Management, Quality System Compliance, Auditing and more. James Stephens has 3 emails and 3 mobile phone numbers on RocketReach.
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