Leah Applewhite
Director Of Quality Assurance
About
I am a Quality & Regulatory executive professional, with 18+ years of experience in Medical Device and In-Vitro Diagnostic (IVD) Devices. Extensive 21 CFR Part 820, 830, & 11, ISO 13485:2016, ISO 9001:2015, ISO 14971:2019, & ISO 11737-2:2019, MDD/MDR, IVDD/IVDR, and MDSAP gap analysis and implementation experience. ASQ Certified Auditor and Certified Six Sigma Green Belt. PMI Project Manager and MBA - Project Management. I am a strategic, but hands-on leader, with a passion for training and coaching others.
Contact Information
Professional Email
****@****.com
Personal Email
****@****.com
Work Phone
(***) ***-***
Mobile
(***) ***-***
Local Location
San Diego County, California, United States
Industry
Medical Device
Designation
Director Of Quality Assurance
Birthday
-
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