Senior Regulatory Affairs Specialist @ (July 2019 - September 2022)
Quality and Regulatory Manager @ (September 2018 - July 2019)
Quality and Regulatory Manager @ (June 2016 - December 2017)
Director of Solutions @ Safis Solutions, LLC (October 2015 - May 2016)
Solutions Delivery Manager - Team Manager @ (May 2013 - September 2015)
Program Manager - Electronics @ (August 2011 - May 2013)
Medical Device Quality and Regulatory Consultant @ Various Medical Device Companies (January 2008 - September 2011)
Owner @ Performance Driven LLC (January 2006 - January 2011)
Project Manager @ (January 2005 - January 2008)
Sr. Supplier Quality Engineer @ (January 2001 - January 2001)
Brian Gard Education
Xavier University
(Six Sigma Black Belt)
2006-2006
Indiana State University
BS (EET)
1989-1994
Brian Gard Skills
Quality Operations
New Product Rollout
Multi-site
Management Review
Electronic Document
Regulatory Compliance
Six Sigma
FDA GMP
Validation
CAPA
Remediation
Quality Management
21 CFR Part 11
CFR
Black Belt
Corrective Actions
Program Management
ISO 13485
New Product Validation
Supplier Quality
Lean Manufacturing
Quality System
Automotive
Medical Devices
Project Management
Quality Assurance
Quality Control
Continuous Improvement
Cross-functional Team Leadership
Product Development
Management
Corrective and Preventive Action (CAPA)
Supplier Quality Management
Regulatory Affairs
Good Manufacturing Practice (GMP)
U.S. Food and Drug Administration (FDA)
Product Validation
21 CFR
Project Management Office (PMO)
Supplier Development
Supplier Evaluation
Communication
Problem Solving
Medical Device Directive
CE marking
Life Science Industry
Business Process Improvement
Quality Systems
Cross Functional Team
Cross Functional Team Leadership
Quality Engineer
Sales
Public Speaking
Corrective and Preventive Action Capa
Engineering
Rom
Corrective and Preventive Action
Brian Gard Summary
Brian Gard, based in Greensburg, IN, US, is currently a Chief Executive Officer at Gard Regulatory and Quality Consulting LLC. Brian Gard brings experience from previous roles at Philips, EHOB, Inc, Kimball Electronics and Safis Solutions, LLC. Brian Gard holds a 2006 - 2006 Xavier University. With a robust skill set that includes Quality Operations, New Product Rollout, Multi-site, Management Review, Electronic Document and more. Brian Gard has 1 emails and 2 mobile phone numbers on RocketReach.
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