Mark A Durivage

Chester, VA

Medical Devices

Monroe County Community College Jan 2007 - 2019
Adjunct Faculty
Zimmer Biomet Jan 2014 - Nov 2015
Associate Director of Quality Assurance and Regulatory Affairs
Terumo Cardiovascular Systems Feb 2012 - Jan 2014
Manager, Corporate Supplier Quality Engineering
Quality Systems Compliance Llc Feb 2012 - Jan 2014
Managing Principal Consultant
Fresenius Medical Care Aug 2010 - Feb 2012
Quality Systems Engineer

Eastern Michigan University 1999 - 2002
Master of Science, Masters, Management Siena Heights University 1995 - 1998
Bachelor of Applied Science, Bachelors

Quality System
Quality Management
Root Cause Analysis
Quality Assurance
Iso 13485
Spc
Quality Auditing
Quality Control
Six Sigma
Lean Manufacturing
Manufacturing
Iso
Medical Devices
Supplier Quality
Capa
Fda
Fmea
Continuous Improvement
Design of Experiments
Process Improvement
Validation
Kaizen
Gmp
Minitab
Sop
Engineering
Team Building
V&V
Product Development
Operational Excellence
Program Management
Microsoft Office
5S
Risk Management
Iso 9000
Quality Engineering
Process Engineering
Quality Systems
21 Cfr
Consent Decree
Employee Training
Dmaic
Risk Analysis
Statistics
Acceptance Sampling
Trend Analysis
R&D
Hypothesis Testing

Certified Manager of Quality/Organizational Excellence (Cmq/Oe)
Certified Six Sigma Black Belt Cssbb
Certified Quality Auditor Cqa
Certified Quality Engineer Cqe
Certified Reliability Engineer Cre
Certified Biomedical Auditor (Cba)
Certified Software Quality Engineer Csqe
Certified Haccp Auditor (Cha)
Certified Pharmaceutical Gmp Professional (Cpgp)
Global Regulatory Affairs Certification (Rac)
Certified Tissue Bank Specialist (Ctbs)
Certified Supplier Quality Professional (Csqp)
Effci Gmp Auditor
Ifs Pacsecure Auditor
American Society For Quality, License 15319
American Society For Quality, License 14255
American Society For Quality, License 41477
American Society For Quality, License 43527
American Society For Quality, License 7007
American Society For Quality, License 760
American Society For Quality, License 5298
American Society For Quality (Asq), License 988
American Society For Quality, License 334
Regulatory Affairs Professionals Society (Raps)
American Association of Tissue Banks, License 915094
License 15319
License 14255
License 41477
License 43527
License 7007
License 760
License 5298
License 988
License 334
License 915094