
James Vroman
Collaborative software quality professional with demonstrated expertise guiding cross-functional teams through implementation of quality management systems in compliance... | Rochester, Minnesota, United States
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James Vroman’s Emails jv****@cv****.com
James Vroman’s Phone Numbers No phone number available.
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James Vroman’s Location Rochester, Minnesota, United States
James Vroman’s Expertise Collaborative software quality professional with demonstrated expertise guiding cross-functional teams through implementation of quality management systems in compliance with regulatory requirements and standards. Highly skilled in coaching junior personnel to expertly balance both regulatory compliance and business needs. Solid experience representing project team during internal and external audits, culminating in ISO 9001 and 13485 certifications. Demonstrated leader in software quality and regulatory compliance arenas, with proven success guiding teams in remediation for FD483, warning letters and consent decrees. Expertise in: • Agile & Waterfall • 21 CFR Parts 210 & 211 (cGMP) • AIMDD (90/385/EEC) • Audits • ISO 13485 • 21 CFR Part 11 (ER/ES) • IEC 62304 • Risk Management (ISO 14971) • CDMR (SOR 98-282) • 21 CFR Part 820 (QSR) • Regulatory Compliance • Information Security (ISEC)
James Vroman’s Current Industry Wl Gore And Associates
James
Vroman’s Prior Industry
Us Navy
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Ge Government Services
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Colsa
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Syntex Pharmaceuticals
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Caribbean Project Management
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Vroman Systems Validation
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Nne Pharmaplan
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Foster Wheeler
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Skanska Usa Building
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Compli
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Cvrx
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Akorn Pharmaceuticals
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Alcon
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Preventice Solutions
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Ibm Watson Health
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Progress Rail A Caterpillar
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Qcs
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Eliassen
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Spire Health
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Wl Gore And Associates
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Work Experience

Wl Gore And Associates
Software Quality Assurance
Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Spire Health
Senior Software Design Quality Assurance Engineer
Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Eliassen
Software Design Quality Assurance Consultant
Tue Jun 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Qcs
Owner / Software Design Quality Assurance Consultant
Sat May 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Progress Rail A Caterpillar
Software Quality Assurance Engineer
Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Ibm Watson Health
Software Design Quality Assurance Lead
Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Ibm Watson Health
Software Design Quality Assurance Engineer
Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Preventice Solutions
Senior Software Quality Assurance Engineer
Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Alcon
IT Program Quality Manager
Sun Sep 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jun 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Akorn Pharmaceuticals
Senior Validation Consultant
Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Cvrx
Senior Principal Software Quality Engineer
Fri Feb 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Compli
Senior Computer Systems Validation Consultant
Wed Dec 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Skanska Usa Building
Computer Validation & Systems Integration Manager
Mon Sep 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
Foster Wheeler
Associate Director
Fri Jun 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Nne Pharmaplan
Computer Systems/Project Manager
Fri Dec 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Nne Pharmaplan
Project Manager
Sun Mar 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)
Vroman Systems Validation
President / Sr. Computer Systems Validation Consultant
Thu Feb 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Caribbean Project Management
Validation Manager
Wed Feb 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)
Syntex Pharmaceuticals
Information Systems Quality Assurance Specialist
Mon Feb 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time)
Colsa
Systems Analyst I / Senior Test Specialist
Sat Aug 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time)
Colsa
Systems Analyst II / Test Specialist
Sun Oct 01 1989 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jul 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time)
Ge Government Services
Computer Operator
Sun Feb 01 1987 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Oct 01 1989 00:00:00 GMT+0000 (Coordinated Universal Time)
Us Navy
Database Supervisor
Sat Sep 01 1984 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Nov 01 1986 00:00:00 GMT+0000 (Coordinated Universal Time)