Director, Regulatory Affairs, Global RAQA @ (July 2014 - July 2022)
Program Manager, Corporate RAQA @ (April 2011 - June 2014)
QA and QSIP Manager @ (November 2009 - April 2011)
RAQA Manager @ (September 2005 - August 2009)
Project Engineer @ (January 2002 - September 2005)
Amy Delk Education
Texas A&M University
BS (Biomedical Engineering)
1998-2001
Amy Delk Skills
Design Control
ISO 13485
Quality System
CAPA
Cross-functional Team Leadership
Product Development
Medical Devices
Quality Control
Software Documentation
Orthopedic
Manufacturing
ISO
Process Improvement
FMEA
FDA
Regulatory Submissions
ISO 14971
Continuous Improvement
Orthopedics
Public Speaking
Regulatory Affairs
Cross Functional Team
Customer Service
Cross Functional Team Leadership
Research
Program Management
Strategy
Engineering
Amy Delk Summary
Amy Delk, based in Texas, United States, is currently a Senior Director, Regulatory at Hologic, Inc.. Amy Delk brings experience from previous roles at Stryker and Argon Medical Devices. Amy Delk holds a 1998 - 2001 BS in Biomedical Engineering @ Texas A&M University. With a robust skill set that includes Design Control, ISO 13485, Quality System, CAPA, Cross-functional Team Leadership and more. Amy Delk has 1 emails and 1 mobile phone numbers on RocketReach.
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