Principal QA Sterility Assurance Specialist @ (January 2008 - January 2016)
QA Sterility Assurance Director @ (January 2005 - January 2008)
Sterilization Project Engineer @ (January 1996 - January 2005)
Quality Sterilization Engineer @ (January 1990 - January 1996)
Horacio Ireta Education
UCLA
BS (Bioengineering)
Cathedral High School College Preparatory - Los Angeles
UC Irvine
Medical Product Life Cycle and Regulatory Affairs Management Certificate
Horacio Ireta Skills
Product Requirements
Industry standards
Communication
Bioburden
Leadership
Aseptic Technique
Manufacturing Operations
GxP
Product Development
Auditing
Regulatory Submissions
Engineering
Engineering Management
Laboratory Information Management System (LIMS)
Quality Management
Project Management
Cross-functional Team Leadership
Validation
FDA
GMP
Quality Assurance
Manufacturing
Sterilization
Clean Rooms
Continuous Improvement
ISO 13485
Lean Manufacturing
Medical Devices
Quality System
CAPA
Quality Control
R&D
Pharmaceutical Industry
21 CFR Part 11
Aseptic Processing
Regulatory Affairs
GLP
SOP
Change Control
U.S. Food and Drug Administration (FDA)
Computer System Validation
Design Control
cGMP manufacturing
Abbreviated New Drug Application (ANDA)
Drug Delivery
5S
QRM
OOS
Productivity Improvement
Note Taking
Telecommuting
Time Management
Organization Skills
Horacio Ireta Summary
Horacio Ireta, based in Oceanside, CA, US, is currently a QA Manager - Sterilization, Microbiology, and Environment Controls at MicroVention-Terumo. Horacio Ireta brings experience from previous roles at Sparsha Pharma USA, Inc., B.Braun Medical Inc., Covidien (Medtronic Minimally Invasive Therapies Group) and B. Braun Medical. Horacio Ireta holds a BS in Bioengineering @ UCLA. With a robust skill set that includes Product Requirements, Industry standards, Communication, Bioburden, Leadership and more. Horacio Ireta has 6 emails and 5 mobile phone numbers on RocketReach.
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