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Sandy Hedberg Location
Clinton, TN, US
Sandy Hedberg Work
2023 -now Vice President of Quality and Regulatory Affairs @
2023 -2023 Indpendent Consultant @ Self-employed
2019 -2023 Director of Quality and Regulatory Affairs @
2001 -2019 Partner @ SoftwareCPR
1997 -2002 Manager, Validation and Metrology @ Aventis Bio-Services
1992 -1997 Manager, Regulatory Affairs @ IDM
Sandy Hedberg Education
William Beaumont Hospital 1982-1984
Michigan Technological University 1979-1983
Sandy Hedberg Skills
Auditing
Quality Management
Regulations
Design Control
510 K
ISO 14971
SDLC
Root Cause Analysis
cGMP
GMP
Process Validation
Biotechnology
Regulatory Affairs
Change Control
Software Documentation
Validation
Process Improvement
Medical Devices
Quality Assurance
Technical Writing
Compliance
Regulatory Requirements
Quality System
V&V
Risk Management
Quality Auditing
QSR
Cross Functional Team Leadership
Document Management
Change Management
Healthcare Information Technology
Pharmaceutics
Training
u.s. Food and Drug Administration Fda
Regulatory Submissions
Business Process Improvement
Software Quality Assurance
Documentation
Informatics
Project Management
Problem Solving
Continuous Improvement
CAPA
Quality Systems
FDA
Sop
21 CFR Part 11
ISO 13485
Internal Audit
u.s. Food and Drug Administration
Sandy Hedberg Summary
Sandy Hedberg, based in Clinton, TN, US, is currently a Vice President of Quality and Regulatory Affairs at ARC-One Solutions. Sandy Hedberg brings experience from previous roles at Self-employed, USDM Life Sciences, SoftwareCPR and Aventis Bio-Services. Sandy Hedberg holds a 1982 - 1984 William Beaumont Hospital. With a robust skill set that includes Auditing, Quality Management, Regulations, Design Control, 510 K and more. Sandy Hedberg has 1 emails and 1 mobile phone numbers on RocketReach.
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