Warren Opfer Email & Phone Number
President and Principal Consultant @ Life Science Services International (LSSI)
5 free lookup(s).
Warren Opfer Location
- Dayton, OH, US
Warren Opfer Work
- 1992 -now President and Principal Consultant @
- 2021 -now Senior SME Consultant in Computer System Validation Center of Excellence @
- 2020 -2021 Senior Consultant - EU MDR Subject Matter Expert @ RQM+ / Maetrics
- 2019 -2020 Sr. Risk Management SME Consultant @ Becton Dickinson & Company
- 2018 -2019 Senior SME Leader for EU MDR Gap Assessment @
- 2019 -2019 Senior Pharma and Medical Device SME Lead for a Pharma and EU MDR assessment and remediation project @
- 2018 -2018 Interim Head of Quality Systems @ Devicor Medical
- 2018 -2018 Senior EU MDR SME Consultant @
- 2017 -2017 Design Control Coach @
- 2016 -2016 Executive Management Consultant - Resolved FDA Compliance Issues @ Confidential
- 2015 -2016 Consultant - Interim Director of Quality (Management Representative) @
- 2014 -2014 Consultant - Project Manager and SME for Compliance Improvement Program @
- 2013 -2013 Consultant - Interim Vice President of Quality Systems @ Engisystems, Inc.
- 2012 -2012 Consultant - Project Manager and Quality and Regulatory SME @
- 2011 -2011 Consultant - Project Manager and SME, Quality System Remediation @
- 2010 -2011 Consultant - Program Manager and SME, Quality System Remediation @
- 1995 -2010 COO and Principal Program and Project Management Consultant @ The Dayton Group, Inc. (TDG)
- 2000 -2010 Consultant - Project Manager and SME Consultant @
- 2008 -2009 Consultant - Project Manager and SME Consultant @
- 2007 -2008 Consultant - Project Manager and SME Consultant @
- 2006 -2007 Consultant - Engagement Executive and Project Manager and SME @ Datascope - InterVascular
- 2006 -2007 Consultant - Quality System SME Consultant @
- 2005 -2006 Consultant - Project Manager and Senior Consultant @
- 2002 -2006 Consultant - Project Manager and SME Consultant for Cordis and DePuy @
- 2003 -2004 Consultant - Project Manager and SME Consultant @
- 1999 -2000 Engagement Executive, Project Manager, and Investigator @
- 1995 -1999 Consultant - Project Manager and SME Consultant @
- 1996 -1997 Consultant - Project Manager and SME Consultant @
- 1995 -1996 Consultant - Project Manager and Senior Consultant @
- 1994 -1995 Consultant - Project Manager and SME Consultant @ Lake County, Indiana
- 1991 -1994 Senior Vice President @ Moore Corporation - Sabre Systems Division
- 1989 -1991 Senior Vice President, Systems @ Cole-Layer-Trumble
Warren Opfer Education
- Wright State University
MBA (Industrial & Production Mgmt/Economics)
- University of Strathclyde
(Leadership and Project Mgmt)
- Wright State University
Master of Business Administration - MBA (Production Management & Economics)
- Wright State University
BS (Business Mgmt/Computer Science)
- NSF Seminar
(ISO 13485:2016 & MDSAP)
Warren Opfer Skills
- FDA
- Quality Assurance
- Quality System
- CAPA
- Validation
- Change Control
- GMP
- Six Sigma
- Medical Devices
- V&V
- Process Improvement
- Cross-functional Team Leadership
- ISO 13485
- Program Management
- Strategy
- Quality Auditing
- Quality Management
- Lean Manufacturing
- Computer System Validation
- GxP
- Regulatory Affairs
- PMP
- 21 CFR Part 11
- Testing
- Software Documentation
- Biotechnology
- Sop
- Leadership
- Quality Control
- ISO
- Manufacturing
- SDLC
- Strategic Planning
- Integration
- Project Planning
- Team Building
- Business Process
- PMO
- Continuous Improvement
- Project Portfolio Management
- Software Project Management
- Product Development
- Process Development
- ERP
- Pharmaceuticals
- Design Control
- ISO 14971
- Management
- Operations Management
- Project Management
- Quality System Inspection Technique
- Cross Functional Team Leadership
- Training
- Product Life Cycle Management
- Inspection
- Organizational Change Agent
- Risk Management
Warren Opfer Summary
- Warren Opfer, based in Dayton, OH, US, is currently a President and Principal Consultant at Life Science Services International (LSSI). Warren Opfer brings experience from previous roles at Jabil Healthcare, RQM+ / Maetrics, Becton Dickinson & Company and B. Braun Group. Warren Opfer holds a MBA in Industrial & Production Mgmt/Economics @ Wright State University. With a robust skill set that includes FDA, Quality Assurance, Quality System, CAPA, Validation and more. Warren Opfer has 3 emails and 2 mobile phone numbers on RocketReach.
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