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Amy Gutierrez Location
Lake Forest, CA, US
Amy Gutierrez Work
Director Regulatory Compliance @ (March 2019 - Present)
Sr. Manager PLM @ (January 2017 - Present)
Sr. Manager Quality Systems @ (October 2015 - January 2017)
Senior Manager, Customer Quality @ (October 2012 - October 2015)
Manager of Complaints @ Advanced Sterilization Products (January 2010 - October 2012)
Manager, Customer Quality @ (January 2005 - January 2010)
Amy Gutierrez Education
University of Phoenix
Amy Gutierrez Skills
Leadership
Defining Requirements
Project Management
Change Control
Auditing
Field Service Management
Continuous Improvement
Supplier Quality Management
Risk Management
Standard Operating Procedure (SOP)
Quality Management
Regulatory Compliance
Problem Solving
Investigation
Remediation
U.S. Food and Drug Administration (FDA)
Audit Management
Quality System Compliance
Complaint Management
Product Lifecycle Management
Change Management
ISO 13485
Medical Devices
FDA
Six Sigma
Cross-functional Team Leadership
Corrective and Preventive Action (CAPA)
GMP
Quality System
Quality Assurance
U.S. Title 21 CFR Part 11 Regulation
Design Control
Amy Gutierrez Summary
Amy Gutierrez, based in Lake Forest, CA, US, is currently a Director Regulatory Compliance at Advanced Sterilization Products (ASP). Amy Gutierrez brings experience from previous roles at Johnson & Johnson, Advanced Sterilization Products (ASP) and Advanced Sterilization Products. Amy Gutierrez holds a University of Phoenix. With a robust skill set that includes Leadership, Defining Requirements, Project Management, Change Control, Auditing and more. Amy Gutierrez has 1 emails and 3 mobile phone numbers on RocketReach.
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