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Holly Huber Location
Rochester, NY, US
Holly Huber Work
Head of Product Quality @ (December 2022 - Present)
Head of Product Quality @ (August 2021 - December 2022)
Head of Design Quality and Surveillance @ (May 2018 - January 2022)
Senior Manager New Product and Life Cycle Management Quality @ (May 2015 - May 2018)
Prinicipal Project Engineer - New Product Design Quality @ (May 2011 - May 2015)
Design Quality Program Manager @ (January 2010 - May 2011)
Quality Assurance Manager @ (November 2006 - January 2010)
Quality Assurance Manager @ (October 2005 - November 2006)
Quality Assurance Manager and Quality Engineer @ (August 2002 - October 2005)
Senior Quality Coach @ (January 2001 - January 2002)
Manufacturing Resource Team Manager - Technology Transfer Project Manager @ (January 1996 - January 2001)
Holly Huber Education
Rochester Institute of Technology
Graduate Certificate (Systems Engineering)
2009-2009
Rochester Institute of Technology
BSME (Mechanical Eingineering)
1987-1992
Rochester Institute of Technology
MS AMS (Statistics)
Holly Huber Skills
Quality System
V&V
Design Control
21 Cfr 820
Business Process Improvement
FDA
R&d
21 CFR Part 11
ISO 13485
Cross Functional Team Leadership
FMEA
ISO
Black Belt
Continuous Improvement
FDA GMP
Medical Devices
Design for Manufacturing
Engineering
Compliance
Regulatory Requirements
Hardware Diagnostics
DMAIC
Root Cause Analysis
Quality Auditing
GMP
Six Sigma
ISO 14971
Technology Transfer
Process Simulation
Green Belt
Process Engineering
Quality Management
Quality Assurance
Minitab
CAPA
Biomedical Engineering
u.s. Food and Drug Administration Fda
Quality Systems
Customer Service
Lean Manufacturing
Cross Functional Team
Manufacturing Engineering
SPC
Value Stream Mapping
Manufacturing
Verification and Validation V&V
Product Development
Validation
Business Analysis
Kaizen
Process Improvement
Change Control
u.s. Food and Drug Administration
Verification and Validation
Holly Huber Summary
Holly Huber, based in Rochester, NY, US, is currently a Head of Product Quality at QuidelOrtho. Holly Huber brings experience from previous roles at Ortho Clinical Diagnostics. Holly Huber holds a 2009 - 2009 Graduate Certificate in Systems Engineering @ Rochester Institute of Technology. With a robust skill set that includes Quality System, V&V, Design Control, 21 Cfr 820, Business Process Improvement and more. Holly Huber has 4 emails and 1 mobile phone numbers on RocketReach.
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