2012 -now Quality Systems Consultant @ Self Employed
2022 -2024 Director of Quality @
2011 -2012 Director, Quality Assurance and Regulatory Affairs @
2004 -2011 Senior Quality Manager @
2002 -2004 Owner @ North Shore Cleaning, Kauai, HI
2001 -2002 Director, Quality Assurance and Regulatory Affairs @ U & I Corporation
1993 -2001 Sr. Manager, Quality Assurance and Regulatory Compliance @ InnerDyne, Inc.
1990 -1993 Senior Quality Engineer and Quality Engineering Manager @
1986 -1990 Quality Supervisor @ Symbion
1986 -1989 Manufacturing Lead @ EFI Incorporated
Robert Malone Education
University of Phoenix
Bachelor of Science (BS) (Business Administration, Quality Assurance, Management and Operations)
1990-1992
Robert Malone Skills
Regulatory Requirements
Analytical Skills
Data Analysis
Materials
Medical Devices
ISO 13485
FDA
GMP
Design Control
CAPA
V&V
Validation
Quality Assurance
Regulatory Affairs
Injection Molding
Quality Auditing
Commercialization
Lean Manufacturing
Quality Control
R&D
Quality System
Manufacturing
Quality Management
Orthopedic
Change Control
GLP
Sop
ISO
21 CFR Part 11
ISO 14971
SPC
GxP
Employee Training
Robert Malone Summary
Robert Malone, based in Salt Lake City, UT, US, is currently a Director of Quality Assurance at BrioHealth Solutions. Robert Malone brings experience from previous roles at Self Employed, CH Biomedical (USA) Inc., The Synergy Company and World Heart, Inc.. Robert Malone holds a 1990 - 1992 Bachelor of Science (BS) in Business Administration, Quality Assurance, Management and Operations @ University of Phoenix. With a robust skill set that includes Regulatory Requirements, Analytical Skills, Data Analysis, Materials, Medical Devices and more. Robert Malone has 3 emails and 3 mobile phone numbers on RocketReach.
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