2023 -now Compliance Manager, Quality Assurance and Regulatory @
2021 -2023 Director Quality Assurance Regulatory Affairs @
2021 -2021 Director Quality Systems @
2018 -2021 Director Global Quality @
2016 -2018 Director of Quality Assurance and Regulatory Affairs @
2016 -2016 Senior Regulatory Affairs Manager @ Bradshaw- A company of In'Tech Medical
2014 -2016 Senior Auditor (QMS) @
2012 -2015 Global Quality Assurance Director - QMS @
2009 -2012 QARA Sr. Site Leader @
2005 -2009 Global Quality Systems Programs Manager @
2002 -2004 FDA Compliance Manager @
2003 -2003 Program Manager @
1997 -2002 Quality Assurance Manager @
1996 -1997 Quality Control Manager @
1991 -1996 Quality Control Manager @ Sampson Coatings
Mark Harper Education
Cardinal Stritch University
MIS (Management Information Systems)
2008-2010
Virginia Commonwealth University
(Business Administration)
1986-1991
Mark Harper Skills
Digital Printing
Microsoft Excel
Manufacturing
Networking
Customer Service
Lean Manufacturing
Account Management
Small Business
Leadership
Six Sigma
Quality Management
Design Control
ISO 14971
Verification and Validation V&V
Computer System Validation
Root Cause Analysis
GMP
ISO
GxP
Change Control
Regulatory Affairs
Supplier Quality
Validation
Process Improvement
Iso 9000
Quality Assurance
Medical Devices
Corrective and Preventive Action Capa
Regulatory Requirements
Quality System
V&V
Program Management
Quality Auditing
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Regulatory Submissions
Quality Control
ISO Standards
CAPA
FDA
R&d
Sop
21 CFR Part 11
ISO 13485
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Mark Harper Summary
Mark Harper, based in Cape Coral, FL, US, is currently a Compliance Manager, Quality Assurance and Regulatory at Bridge to Life Ltd.. Mark Harper brings experience from previous roles at Bridge to Life Ltd., Spectrum Plastics Group and Bradshaw- A company of In'Tech Medical. Mark Harper holds a 2008 - 2010 MIS in Management Information Systems @ Cardinal Stritch University. With a robust skill set that includes Digital Printing, Microsoft Excel, Manufacturing, Networking, Customer Service and more. Mark Harper has 2 emails and 1 mobile phone numbers on RocketReach.
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