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Alexandra Williamson Location
Hockessin, DE, US
Alexandra Williamson Work
2025 -now Associate Vice President of Quality Assurance @
2022 -2025 Senior Director Quality Assurance @
2019 -2022 Director of Quality and Regulatory Affairs @ Qfix
2017 -2019 Quality Assurance Manager @ Qfix
2003 -2016 Quality Assurance Manager @
1996 -2002 Senior Associate Scientist and Lab Supervisor @
Alexandra Williamson Education
University of Delaware
Bachelor’s Degree (Biology)
1994-1996
Widener University Schools of Law
Associate’s Degree (Legal Studies)
1990-1991
Alexandra Williamson Skills
Medical Devices
Class I, II, & III Medical Devices
Management Representative
Leadership
Global Regulatory Compliance
Medical Device Single Audit Program
U.S. Food and Drug Administration (FDA)
European Union Medical Device Regulation (EU MDR 2017/745), Class I & Class II
State-of-the-art standards
EN ISO 13485:2016+A11:2021
EN ISO 14971:2019+A11:2021
Quality Management System
Risk Management
Post Market Surveillance Leadership
Complaint Management
Adverse Event Reporting
Recalls, Product Advisories and Field Actions
Clinical Evaluation Plans & Reports
Customer Facing Roles
Biocompatibility
Design & Development
Design Transfer
Verification and Validation (V&V)
Training & Development
People Management
Auditing
Change Management
Project Management
Nonconformances
Lean Manufacturing
Investigation
Analytical Skills
Data Analysis
Medical Device Directive
Project Planning
Manufacturing
Six Sigma
Root Cause Analysis
Deviation Management
Cross-functional Team Leadership
Continuous Improvement
Corrective and Preventive Action (CAPA)
Quality System
Class III Medical Devices
Complaint Investigations
Product Launch
Class Ii Medical Devices
Non Conforming
Validation
Microsoft Excel
Product Design
Product Management
Iso 10993
Life Sciences
Quality Management
Microsoft Word
u.s. Food and Drug Administration Fda
Microsoft Office
Cell Culture
ISO 14971
ISO 13485
Corrective And Preventive Action Capa
Cross Functional Team Leadership
u.s. Food and Drug Administration
Corrective and Preventive Action
Alexandra Williamson Summary
Alexandra Williamson, based in Hockessin, DE, US, is currently a Associate Vice President of Quality Assurance at Neuronetics, Inc.. Alexandra Williamson brings experience from previous roles at Neuronetics, Inc., Qfix and Terumo Medical Corporation. Alexandra Williamson holds a 1994 - 1996 Bachelor’s Degree in Biology @ University of Delaware. With a robust skill set that includes Medical Devices, Class I, II, & III Medical Devices, Management Representative, Leadership, Global Regulatory Compliance and more. Alexandra Williamson has 3 emails and 5 mobile phone numbers on RocketReach.
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