Brian McGinnis
Regulatory Affairs/ Quality Assurance Manager at Summus Medical Laser- Claim this Profile
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Bio
Credentials
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Lead Auditor to ISO 13485:2016
British Standards InstituteOct, 2018- Nov, 2024 -
LAT (Laboratory Animal Technician)
AALASJan, 1992- Nov, 2024 -
ALAT (Assistant Laboratory Animal Technician)
AALASJan, 1991- Nov, 2024
Experience
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Summus Medical Laser
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs/ Quality Assurance Manager
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Aug 2017 - Present
Established and validated Quality Management System (QMS) processes, policies, and procedures in accordance to 21 CFR Part 820 and ISO 13485. Created and maintained technical file information relevant to the Medical Device Directive (MDD) and applicable medical device regulations to uphold compliance. Created, filed, maintained and archived quality documents and records through established system audits, corrective and preventative actions and root cause analysis. Liaised between Senior Management, U.S. Federal and European Notified Bodies, and contract manufacturers to provide professional guidance on training and continual improvement of processes to guarantee product safety and regulatory compliance.
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Vanderbilt University Medical Center
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United States
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Hospitals and Health Care
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700 & Above Employee
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Facilities Manager
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Jun 2011 - Jan 2017
Managed direct reports in multiple facilities governed by the USDA, Internal Division and Safety Committees and an Accreditation Institution providing continued successful reviews. Responsible for multitasking daily workflow through mentoring and continuous improvement, training, performance evaluations, productivity, efficiency, and profitability through the implementation of effective methods and strategies in a teamwork environment ensuring safety and full employee gratification. Managed direct reports in multiple facilities governed by the USDA, Internal Division and Safety Committees and an Accreditation Institution providing continued successful reviews. Responsible for multitasking daily workflow through mentoring and continuous improvement, training, performance evaluations, productivity, efficiency, and profitability through the implementation of effective methods and strategies in a teamwork environment ensuring safety and full employee gratification.
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Facilities Manager
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Jun 2004 - May 2011
Managed multiple research buildings for the worlds largest pharmaceutical business. Responsible for compliance of FDA and USDA federal governing bodies, veterinary welfare, safety, and quality process audits. Facilitated daily meetings to provide detailed instruction, the enforcement of policies and effective scheduling of workflow and equipment maintenance in a strict GLP environment. Accountable for environmental and physical monitoring of facilities and equipment with promptly securing resources and scheduling corrective measures in support of efficiency and clinical study time lines.
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Education
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Michigan State University
Bachelor's Degree, Animal Science
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