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Sandra Hansen Location
California, United States
Sandra Hansen Work
Director, Regulatory and Quality @ (July 2024 - Present)
Director RA and QA @ (June 2022 - July 2024)
Director Quality Assurance Regulatory Affairs @ (November 2020 - June 2022)
Director, QA, RA @ (June 2019 - November 2020)
Director Of Quality @ (June 2018 - June 2019)
Director of Quality Systems and Compliance @ (October 2015 - June 2018)
Regulatory Affairs Manager @ (January 2013 - October 2015)
QA Manager @ (January 2007 - January 2013)
QA Manager @ OCO Biomedical (April 2001 - December 2006)
Document Control @ Cell Robotics (January 1997 - January 2001)
Sandra Hansen Education
New Mexico State University 1985-1992
Sandra Hansen Skills
Auditing
ISO 13485
ISO 14971
Regulatory Affairs
Cross-functional Team Leadership
Quality Assurance
Quality System
Medical Devices
GMP
CAPA
Design Control
V&V
R&D
Biomedical Engineering
Validation
FDA
FDA GMP
Biotechnology
Change Control
21 CFR Part 11
Design of Experiments
Product Launch
Capital Equipment
Product Development
Quality Auditing
CQA
Medical Device Directive
21 CFR
Iso 9000
CE marking
Software Documentation
Manufacturing
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Cross Functional Team
Corrective and Preventive Action Capa
u.s. Food and Drug Administration Fda
Sales
Compliance
Microsoft Excel
Quality Systems
Cross Functional Team Leadership
Troubleshooting
See 16+see Less
Marketing
Microsoft Office
Corrective and Preventive Action
u.s. Food and Drug Administration
Sandra Hansen Summary
Sandra Hansen, based in California, United States, is currently a Director, Regulatory and Quality at Rohrer Aesthetics. Sandra Hansen brings experience from previous roles at IntraOp Medical Corporation, IntraVu, Inc., Xoft, a subsidiary of iCAD, Inc. and Cutera, Inc.. Sandra Hansen holds a 1985 - 1992 New Mexico State University. With a robust skill set that includes Auditing, ISO 13485, ISO 14971, Regulatory Affairs, Cross-functional Team Leadership and more. Sandra Hansen has 2 emails and 2 mobile phone numbers on RocketReach.
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