Quality Assurance Project Engineer @ (January 1997 - December 1999)
Senior Quality Assurance Engineer @ (May 1995 - December 1996)
Industrial Engineer @ (June 1991 - May 1995)
Michele Wootten Education
Lehigh University 1987-1991
Michele Wootten Skills
Design of Experiments
21 CFR Part 11
ISO 13485
Medical Devices
Regulatory Affairs
Six Sigma
Supplier Quality
Design Control
Computer System Validation
FDA
FMEA
ISO 14971
Quality System
CQE
Sop
CAPA
Quality Management
Minitab
Lean Manufacturing
Validation
Change Control
21 CFR
V&V
DMAIC
GMP
ISO
Quality Auditing
SPC
Root Cause Analysis
Biomedical Engineering
Aseptic Processing
Biopharmaceuticals
Kontinuierliche Verbesserung
Michele Wootten Summary
Michele Wootten, based in Franklin Lakes, NJ, US, is currently a WW VP Quality Management at BD. Michele Wootten brings experience from previous roles at BD. Michele Wootten holds a 1987 - 1991 Lehigh University. With a robust skill set that includes Design of Experiments, 21 CFR Part 11, ISO 13485, Medical Devices, Regulatory Affairs and more. Michele Wootten has 4 emails and 3 mobile phone numbers on RocketReach.
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