Regulatory and Quality Solutions LLC (R&Q)
Industry: Company
DescriptionFounded: 2008
Regulatory and Quality Solutions LLC (R&Q) List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Regulatory and Quality Solutions LLC (R&Q). You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Regulatory and Quality Solutions LLC (R&Q) Employees
Employee
Years
Job
Industry
Michael Metcalf Michael Metcalf's Regulatory and Quality Solutions LLC (R&Q) Experience August 2014 - Present
Job Associate Engineer at Regulatory & Quality Solutions, LLC
Industry Biotechnology
Experience
Regulatory and Quality Solutions LLC (R&Q) August 2014 - Present
Invacare May 2013 - August 2013
Swensons Drive-In May 2012 - May 2013
Invacare Corporation August 2012 - December 2012
Invacare January 2012 - May 2012
The University of Akron August 2010 - April 2012
The University of Akron May 2011 - August 2011
The University of Akron January 2010 - August 2010
Skills
Leadership, Engineering, Analysis, Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Public Speaking, Matlab, Time Management, SolidWorks, Research, Biomedical Engineering, Medical Devices, Data Analysis, AutoCAD, R&D
Education
The University of Akron 2009 — 2014
Bachelor of Science (B.S.), Biomedical Engineering: Biomaterials/Tissues Track
North Central State College 2007 — 2009
Associate of Technical Studies, Electrical and Mechanical Engineering
Regulatory and Quality Solutions LLC (R&Q) August 2014 - Present
Invacare May 2013 - August 2013
Swensons Drive-In May 2012 - May 2013
Invacare Corporation August 2012 - December 2012
Invacare January 2012 - May 2012
The University of Akron August 2010 - April 2012
The University of Akron May 2011 - August 2011
The University of Akron January 2010 - August 2010
Skills
Leadership, Engineering, Analysis, Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Public Speaking, Matlab, Time Management, SolidWorks, Research, Biomedical Engineering, Medical Devices, Data Analysis, AutoCAD, R&D
Education
The University of Akron 2009 — 2014
Bachelor of Science (B.S.), Biomedical Engineering: Biomaterials/Tissues Track
North Central State College 2007 — 2009
Associate of Technical Studies, Electrical and Mechanical Engineering
Meredith Rea Meredith Rea's Regulatory and Quality Solutions LLC (R&Q) Experience 2013 - 2013
Job Student at Duquesne University School of Education
Industry Education Management
Experience
Johnny's Hallmark August 2012 - Present
The Lakeside Creamery/FunTime Water Sports June 2011 - Present
The Ohio State University August 2013 - 2015
Regulatory and Quality Solutions LLC (R&Q) 2013 - 2013
Skills
Microsoft Office, Leadership, Social Media, Marketing, Customer Service, PowerPoint, Public Speaking, Event Planning, Microsoft Word, Research, Social Networking, Microsoft Excel, Teaching, Working With Children
Education
Duquesne University 2015 — 2018
Junior High/Intermediate/Middle School Education and Teaching, Sophomore
The Ohio State University 2013 — 2015
Marketing, Sophomore
Franklin Regional Senior High School 2009 — 2013
Johnny's Hallmark August 2012 - Present
The Lakeside Creamery/FunTime Water Sports June 2011 - Present
The Ohio State University August 2013 - 2015
Regulatory and Quality Solutions LLC (R&Q) 2013 - 2013
Skills
Microsoft Office, Leadership, Social Media, Marketing, Customer Service, PowerPoint, Public Speaking, Event Planning, Microsoft Word, Research, Social Networking, Microsoft Excel, Teaching, Working With Children
Education
Duquesne University 2015 — 2018
Junior High/Intermediate/Middle School Education and Teaching, Sophomore
The Ohio State University 2013 — 2015
Marketing, Sophomore
Franklin Regional Senior High School 2009 — 2013
Suyesh Acharya Suyesh Acharya's Regulatory and Quality Solutions LLC (R&Q) Experience May 2015 - Present
Job Engineer at Regulatory and Quality Solutions LLC (R&Q)
Industry Biotechnology
Experience
Regulatory and Quality Solutions LLC (R&Q) May 2015 - Present
R&Q June 2013 - May 2015
ALung Technologies February 2013 - April 2013
Human Movement and Balance Lab January 2010 - December 2012
FDA June 2012 - August 2012
Chipotle Mexican Grill September 2011 - May 2012
University of Pittsburgh August 2010 - November 2011
Hannover Medical School May 2011 - August 2011
National Institutes of Health June 2010 - August 2010
Skills
Matlab, Biomechanics, Biomedical Engineering, Solidworks, CAD, Motion Capture, Microsoft Office, Regulatory Affairs, Human Factors..., Data Analysis, Bioengineering, Biotechnology
Education
University of Pittsburgh 2009 — 2013
B.S. Bioengineering, Biomedical Engineering with Mechanical Engineer Minor, Graduate Summa Cum Laude
Moon Area High School 2005 — 2009
High School Diploma
Regulatory and Quality Solutions LLC (R&Q) May 2015 - Present
R&Q June 2013 - May 2015
ALung Technologies February 2013 - April 2013
Human Movement and Balance Lab January 2010 - December 2012
FDA June 2012 - August 2012
Chipotle Mexican Grill September 2011 - May 2012
University of Pittsburgh August 2010 - November 2011
Hannover Medical School May 2011 - August 2011
National Institutes of Health June 2010 - August 2010
Skills
Matlab, Biomechanics, Biomedical Engineering, Solidworks, CAD, Motion Capture, Microsoft Office, Regulatory Affairs, Human Factors..., Data Analysis, Bioengineering, Biotechnology
Education
University of Pittsburgh 2009 — 2013
B.S. Bioengineering, Biomedical Engineering with Mechanical Engineer Minor, Graduate Summa Cum Laude
Moon Area High School 2005 — 2009
High School Diploma
Ronnie Mahofski Ronnie Mahofski's Regulatory and Quality Solutions LLC (R&Q) Experience August 2015 - Present
Job Director of Account Management at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) August 2015 - Present
Regulatory and Quality Solutions LLC (R&Q) February 2015 - August 2015
Circadiance August 2010 - February 2015
MEDRAD November 2002 - August 2010
GE Energy 2000 - 2002
US Navy - USS Tennessee (SSBN 734) 1995 - 2000
Skills
Product Development, Six Sigma, Manufacturing, Continuous Improvement, Process Improvement, Black Belt, Medical Devices, Engineering, Lean Manufacturing, Project Management, Quality Assurance, Cross-functional Team..., Root Cause Analysis, ISO 13485, Design Control, Leadership, Management, Quality System, FMEA, R&D, Procurement, Engineering Management, FDA, CAPA, V&V, DMAIC, Design for Manufacturing, Design of Experiments, SPC, Validation, Quality Management, Process Simulation, ISO, Injection Molding, Manufacturing..., Supplier Quality, Manufacturing Operations, Commercialization, Biomedical Engineering, Value Stream Mapping, Process Engineering, ISO 14971, Product Launch, Manufacturing...
Education
United States Naval Academy 1991 — 1995
Bachelor's Degree, Systems Engineering, 3.47
Waynesburg University 2007 — 2008
MBA, Finance
Regulatory and Quality Solutions LLC (R&Q) August 2015 - Present
Regulatory and Quality Solutions LLC (R&Q) February 2015 - August 2015
Circadiance August 2010 - February 2015
MEDRAD November 2002 - August 2010
GE Energy 2000 - 2002
US Navy - USS Tennessee (SSBN 734) 1995 - 2000
Skills
Product Development, Six Sigma, Manufacturing, Continuous Improvement, Process Improvement, Black Belt, Medical Devices, Engineering, Lean Manufacturing, Project Management, Quality Assurance, Cross-functional Team..., Root Cause Analysis, ISO 13485, Design Control, Leadership, Management, Quality System, FMEA, R&D, Procurement, Engineering Management, FDA, CAPA, V&V, DMAIC, Design for Manufacturing, Design of Experiments, SPC, Validation, Quality Management, Process Simulation, ISO, Injection Molding, Manufacturing..., Supplier Quality, Manufacturing Operations, Commercialization, Biomedical Engineering, Value Stream Mapping, Process Engineering, ISO 14971, Product Launch, Manufacturing...
Education
United States Naval Academy 1991 — 1995
Bachelor's Degree, Systems Engineering, 3.47
Waynesburg University 2007 — 2008
MBA, Finance
Lynn Kibblehouse's Regulatory and Quality Solutions LLC (R&Q) Experience April 2015 - August 2015
Job Experienced business development professional, regulatory services, medical device
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) April 2015 - August 2015
UL LLC 2013 - 2015
Nemko February 2012 - July 2013
Intertek Testing Services March 2010 - 2011
Renaissance Electronics corporation 2008 - March 2010
Skills
New Business Development, Laboratory Equipment, Medical Devices, IEC 61010, Salesforce.com, Account Management, Class III Medical..., Selling, 3rd editio, Project Coordination, Standards Compliance, ISO 13485, Environmental Compliance, FDA, UL, RF, Telecommunications, RF Componet Sales, Compliance, Project Implementation, Taking New Products to..., Direct Market Access, Risk Analysis, EMC compliance, Trade Shows, Human Factors..., Gap Analysis, UDI, Cross Selling, Human Factors, ISO Certifications, CE marking, Project Management, Regulatory Compliance, Corrective Actions, Design Control, Process Validation, Quality System, Quality Auditing, Risk Monitoring, Post Market Surveillance, Design Assurance, Sandler
Education
Eastern Illinois University
Bachelor's Degree, Marketing/Economics
Lemont Township
Graduated, Business
Regulatory and Quality Solutions LLC (R&Q) April 2015 - August 2015
UL LLC 2013 - 2015
Nemko February 2012 - July 2013
Intertek Testing Services March 2010 - 2011
Renaissance Electronics corporation 2008 - March 2010
Skills
New Business Development, Laboratory Equipment, Medical Devices, IEC 61010, Salesforce.com, Account Management, Class III Medical..., Selling, 3rd editio, Project Coordination, Standards Compliance, ISO 13485, Environmental Compliance, FDA, UL, RF, Telecommunications, RF Componet Sales, Compliance, Project Implementation, Taking New Products to..., Direct Market Access, Risk Analysis, EMC compliance, Trade Shows, Human Factors..., Gap Analysis, UDI, Cross Selling, Human Factors, ISO Certifications, CE marking, Project Management, Regulatory Compliance, Corrective Actions, Design Control, Process Validation, Quality System, Quality Auditing, Risk Monitoring, Post Market Surveillance, Design Assurance, Sandler
Education
Eastern Illinois University
Bachelor's Degree, Marketing/Economics
Lemont Township
Graduated, Business
Ankitha Rao Ankitha Rao's Regulatory and Quality Solutions LLC (R&Q) Experience July 2015 - Present
Job Senior Specialist at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) July 2015 - Present
R&Q February 2014 - July 2015
Philips Healthcare July 2013 - February 2014
Syner-G Pharma CMC Consulting, LLC January 2013 - April 2013
Arteriocyte June 2012 - December 2012
SERVOMAX INDIA LIMITED April 2010 - May 2012
Skills
Regulatory Affairs, Quality Assurance, Quality Control, Regulatory Submissions, CE marking, FDA, Medical Devices, GMP, CAPA, Quality System, 21 CFR Part 11, Clinical Research, Biotechnology, Regulatory Requirements, IND, SOP
Education
Northeastern University 2011 — 2013
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, 3.7
Jawaharlal Nehru Technological University 2007 — 2011
Bachelor's degree, Pharmacy
Regulatory and Quality Solutions LLC (R&Q) July 2015 - Present
R&Q February 2014 - July 2015
Philips Healthcare July 2013 - February 2014
Syner-G Pharma CMC Consulting, LLC January 2013 - April 2013
Arteriocyte June 2012 - December 2012
SERVOMAX INDIA LIMITED April 2010 - May 2012
Skills
Regulatory Affairs, Quality Assurance, Quality Control, Regulatory Submissions, CE marking, FDA, Medical Devices, GMP, CAPA, Quality System, 21 CFR Part 11, Clinical Research, Biotechnology, Regulatory Requirements, IND, SOP
Education
Northeastern University 2011 — 2013
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, 3.7
Jawaharlal Nehru Technological University 2007 — 2011
Bachelor's degree, Pharmacy
Elizabeth Jodon-Jacewicz Elizabeth Jodon-Jacewicz's Regulatory and Quality Solutions LLC (R&Q) Experience March 2015 - Present
Job Regulatory and Quality Principal Specialist
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) March 2015 - Present
Tornier OrthoHelix January 2014 - March 2015
OrthoHelix Surgical Designs, Division of Tornier, N.V July 2012 - January 2014
Coltene Whaledent April 2011 - July 2012
GOJO Industries April 2007 - April 2011
GOJO Industries January 2004 - April 2007
Chemtron Corp July 2002 - December 2003
GOJO Industries January 2000 - July 2002
Skills
Regulatory Affairs, FDA, R&D, Quality System, Medical Devices, GMP, Quality Assurance, Product Development, ISO 13485, CAPA, Cross-functional Team..., Product Launch, Regulatory Submissions, ISO 14971, Quality Systems, Software Documentation, Design Control, Commercialization, Compliance, Research, Auditing, Documentation, V&V, Biotechnology, Lifesciences, Biomedical Engineering, Pharmaceutical Industry, OTC, Skin Care Products, Quality Management, Microsoft Word
Education
Northeastern University 2007 — 2009
Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices
Antioch College 1995 — 1999
Bachelor of Science (B.S.), Environmental Science
Regulatory and Quality Solutions LLC (R&Q) March 2015 - Present
Tornier OrthoHelix January 2014 - March 2015
OrthoHelix Surgical Designs, Division of Tornier, N.V July 2012 - January 2014
Coltene Whaledent April 2011 - July 2012
GOJO Industries April 2007 - April 2011
GOJO Industries January 2004 - April 2007
Chemtron Corp July 2002 - December 2003
GOJO Industries January 2000 - July 2002
Skills
Regulatory Affairs, FDA, R&D, Quality System, Medical Devices, GMP, Quality Assurance, Product Development, ISO 13485, CAPA, Cross-functional Team..., Product Launch, Regulatory Submissions, ISO 14971, Quality Systems, Software Documentation, Design Control, Commercialization, Compliance, Research, Auditing, Documentation, V&V, Biotechnology, Lifesciences, Biomedical Engineering, Pharmaceutical Industry, OTC, Skin Care Products, Quality Management, Microsoft Word
Education
Northeastern University 2007 — 2009
Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices
Antioch College 1995 — 1999
Bachelor of Science (B.S.), Environmental Science
Tamala Wattree Tamala Wattree's Regulatory and Quality Solutions LLC (R&Q) Experience September 2014 - November 2014
Job Compliance Specialist at Masimo
Industry Medical Devices
Experience
Masimo December 2014 - June 2015
Regulatory and Quality Solutions LLC (R&Q) September 2014 - November 2014
Maetrics LLC May 2013 - July 2014
Allergan November 2011 - February 2013
Hub International March 2011 - November 2011
Santa Barbara Graduate Institute November 2009 - February 2010
CRN Digital Talk Radio November 2008 - June 2009
Skills
Time Management, Marketing, Interviews, Public Relations, Management, Team Building, Customer Service, Customer Satisfaction, Editing, Policy, Proposal Writing, FDA, SAP, Medical Devices, Training, Outlook
Education
California State University-Northridge 2004 — 2007
Master of Arts (M.A.), Mass Communication/Media Studies, 3.6
University of California, Riverside 1999 — 2003
Bachelor of Arts (B.A.), Theater Arts, 3.4
Masimo December 2014 - June 2015
Regulatory and Quality Solutions LLC (R&Q) September 2014 - November 2014
Maetrics LLC May 2013 - July 2014
Allergan November 2011 - February 2013
Hub International March 2011 - November 2011
Santa Barbara Graduate Institute November 2009 - February 2010
CRN Digital Talk Radio November 2008 - June 2009
Skills
Time Management, Marketing, Interviews, Public Relations, Management, Team Building, Customer Service, Customer Satisfaction, Editing, Policy, Proposal Writing, FDA, SAP, Medical Devices, Training, Outlook
Education
California State University-Northridge 2004 — 2007
Master of Arts (M.A.), Mass Communication/Media Studies, 3.6
University of California, Riverside 1999 — 2003
Bachelor of Arts (B.A.), Theater Arts, 3.4
Julia Wnek's Regulatory and Quality Solutions LLC (R&Q) Experience January 2015 - Present
Job Chief Financial Officer at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) January 2015 - Present
R&Q March 2012 - January 2015
Medrad September 2011 - March 2012
Medrad December 2010 - October 2011
Medrad January 2009 - January 2011
MEDRAD, Inc January 2007 - December 2008
Medrad January 2006 - December 2006
Medrad January 2005 - December 2005
Medrad March 2004 - December 2004
KPMG September 2003 - March 2004
Skills
Financial Modeling, Forecasting, Financial Analysis, Pricing, Mergers, Cross-functional Team..., Mergers & Acquisitions, Managerial Finance, Project Management, Medical Devices, Competitive Analysis, Strategic Planning, Process Improvement, Product Development, Finance, Manufacturing, Management, FDA, Six Sigma, Product Management, Return on Investment..., Strategy, Business Analysis, Business Process..., SAP, Start-ups, Quality System, Product Launch
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 2004 — 2006
MBA, Concentration - Marketing
Saint Vincent College 2000 — 2003
B.S., Accounting
Regulatory and Quality Solutions LLC (R&Q) January 2015 - Present
R&Q March 2012 - January 2015
Medrad September 2011 - March 2012
Medrad December 2010 - October 2011
Medrad January 2009 - January 2011
MEDRAD, Inc January 2007 - December 2008
Medrad January 2006 - December 2006
Medrad January 2005 - December 2005
Medrad March 2004 - December 2004
KPMG September 2003 - March 2004
Skills
Financial Modeling, Forecasting, Financial Analysis, Pricing, Mergers, Cross-functional Team..., Mergers & Acquisitions, Managerial Finance, Project Management, Medical Devices, Competitive Analysis, Strategic Planning, Process Improvement, Product Development, Finance, Manufacturing, Management, FDA, Six Sigma, Product Management, Return on Investment..., Strategy, Business Analysis, Business Process..., SAP, Start-ups, Quality System, Product Launch
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 2004 — 2006
MBA, Concentration - Marketing
Saint Vincent College 2000 — 2003
B.S., Accounting
Jude Shellito's Regulatory and Quality Solutions LLC (R&Q) Experience December 2014 - Present
Job Sr. Principal Engineer at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) December 2014 - Present
TRN Technical October 2014 - December 2014
AxioMed Spine Corporation June 2011 - October 2014
Norman Noble, Inc. March 1998 - June 2011
Acromed Corporation August 1993 - March 1998
DePuy AcroMed (formerly AcroMed) 1993 - 1998
TRW August 1985 - March 1993
Skills
Design Control, Medical Devices, V&V, ISO 13485, Iso 9000, CAPA, FDA, Cross-functional Team..., DMAIC, Biomedical Engineering, CQA, Quality Assurance, Process Improvement, Manufacturing, Six Sigma, 5S, Calibration, Continuous Improvement, Design of Experiments, FMEA, GMP, ISO, ISO 14971, Lean Manufacturing, Quality System, R, Root Cause Analysis, SPC, Validation
Education
Gannon University 1981 — 1985
BSMET, Engineering
Regulatory and Quality Solutions LLC (R&Q) December 2014 - Present
TRN Technical October 2014 - December 2014
AxioMed Spine Corporation June 2011 - October 2014
Norman Noble, Inc. March 1998 - June 2011
Acromed Corporation August 1993 - March 1998
DePuy AcroMed (formerly AcroMed) 1993 - 1998
TRW August 1985 - March 1993
Skills
Design Control, Medical Devices, V&V, ISO 13485, Iso 9000, CAPA, FDA, Cross-functional Team..., DMAIC, Biomedical Engineering, CQA, Quality Assurance, Process Improvement, Manufacturing, Six Sigma, 5S, Calibration, Continuous Improvement, Design of Experiments, FMEA, GMP, ISO, ISO 14971, Lean Manufacturing, Quality System, R, Root Cause Analysis, SPC, Validation
Education
Gannon University 1981 — 1985
BSMET, Engineering
Elizabeth Bol's Regulatory and Quality Solutions LLC (R&Q) Experience November 2014 - Present
Job At R&Q Solutions
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) November 2014 - Present
STERIS Corporation April 2013 - November 2014
Steris November 2011 - April 2013
Aeroclay Inc August 2011 - March 2012
Avery Dennison September 2006 - August 2011
Bath and Body Works 2004 - 2006
Skills
Product Development, Chemical Engineering, Lean Manufacturing, Medical Devices, Polymers, Process Improvement, Chemistry, R, Microsoft Word, PowerPoint, Cross-functional Team..., Technical Writing, FTIR, Coatings, Project Management, 5S, Polymer Characterization, Process Optimization, Adhesives, Team Leadership, Kaizen, Process Simulation, Six Sigma, Process Engineering, Rheology
Education
Case Western Reserve University 2009 — 2012
MS, Macromolecular Science and Engineering
University of Minnesota-Duluth 1999 — 2004
BS, Chemical Engineering
Regulatory and Quality Solutions LLC (R&Q) November 2014 - Present
STERIS Corporation April 2013 - November 2014
Steris November 2011 - April 2013
Aeroclay Inc August 2011 - March 2012
Avery Dennison September 2006 - August 2011
Bath and Body Works 2004 - 2006
Skills
Product Development, Chemical Engineering, Lean Manufacturing, Medical Devices, Polymers, Process Improvement, Chemistry, R, Microsoft Word, PowerPoint, Cross-functional Team..., Technical Writing, FTIR, Coatings, Project Management, 5S, Polymer Characterization, Process Optimization, Adhesives, Team Leadership, Kaizen, Process Simulation, Six Sigma, Process Engineering, Rheology
Education
Case Western Reserve University 2009 — 2012
MS, Macromolecular Science and Engineering
University of Minnesota-Duluth 1999 — 2004
BS, Chemical Engineering
Jeanne McNeil's Regulatory and Quality Solutions LLC (R&Q) Experience September 2014 - Present
Job Resource Manager at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) September 2014 - Present
Philips Healthcare March 2014 - September 2014
Philips Children's Medical Ventures May 2013 - March 2014
Philips Children's Medical Ventures December 2011 - May 2013
Philips Healthcare November 2007 - December 2011
Philips Respironics November 2006 - November 2007
Philips Respironics April 2004 - October 2006
Jatco Machine & Tool December 1997 - March 2004
Scientific Systems, Inc October 1991 - April 1992
CorningAsahi Video Products July 1990 - August 1991
Skills
Product Development, Medical Devices, Cross-functional Team..., ISO 13485, FDA, Design Control, Quality System, Process Improvement, R&D, Product Launch, FMEA, Quality Assurance, CAPA, Six Sigma, Quality Management, Manufacturing, Continuous Improvement, DMAIC
Education
Penn State University 2006 — 2009
Master of Project Management, Project Management
Villanova University 1986 — 1990
Bachelor of Mechanical Engineering
Regulatory and Quality Solutions LLC (R&Q) September 2014 - Present
Philips Healthcare March 2014 - September 2014
Philips Children's Medical Ventures May 2013 - March 2014
Philips Children's Medical Ventures December 2011 - May 2013
Philips Healthcare November 2007 - December 2011
Philips Respironics November 2006 - November 2007
Philips Respironics April 2004 - October 2006
Jatco Machine & Tool December 1997 - March 2004
Scientific Systems, Inc October 1991 - April 1992
CorningAsahi Video Products July 1990 - August 1991
Skills
Product Development, Medical Devices, Cross-functional Team..., ISO 13485, FDA, Design Control, Quality System, Process Improvement, R&D, Product Launch, FMEA, Quality Assurance, CAPA, Six Sigma, Quality Management, Manufacturing, Continuous Improvement, DMAIC
Education
Penn State University 2006 — 2009
Master of Project Management, Project Management
Villanova University 1986 — 1990
Bachelor of Mechanical Engineering
Lori Smith-Sakalousky's Regulatory and Quality Solutions LLC (R&Q) Experience January 2015 - Present
Job Vice President of Operations at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) January 2015 - Present
R&Q March 2013 - January 2015
Regulatory and Quality Solutions LLC January 2012 - March 2013
Medrad Inc., a business of Bayer Healthcare 2011 - 2012
MEDRAD Inc., a business of Bayer Healthcare 2008 - 2011
iDL Worldwide 2003 - 2005
LaBarge, Inc. 2003 - 2004
Sony 2000 - 2003
Skills
Lean Manufacturing, Process Improvement, Continuous Improvement, Team Building, Project Management, Medical Devices, Six Sigma, FDA, Quality System, Leadership
Education
Chatham University 2005 — 2007
Master of Business Administration (M.B.A.)
Clarion University of Pennsylvania 1989 — 1991
BS in Business Administration, Concentration in Psychology
Venango Christian
Regulatory and Quality Solutions LLC (R&Q) January 2015 - Present
R&Q March 2013 - January 2015
Regulatory and Quality Solutions LLC January 2012 - March 2013
Medrad Inc., a business of Bayer Healthcare 2011 - 2012
MEDRAD Inc., a business of Bayer Healthcare 2008 - 2011
iDL Worldwide 2003 - 2005
LaBarge, Inc. 2003 - 2004
Sony 2000 - 2003
Skills
Lean Manufacturing, Process Improvement, Continuous Improvement, Team Building, Project Management, Medical Devices, Six Sigma, FDA, Quality System, Leadership
Education
Chatham University 2005 — 2007
Master of Business Administration (M.B.A.)
Clarion University of Pennsylvania 1989 — 1991
BS in Business Administration, Concentration in Psychology
Venango Christian
Marilyn Waxberg's Regulatory and Quality Solutions LLC (R&Q) Experience 2015 - Present
Job Business Expansion Strategist and Senior Principal Consultant
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) 2015 - Present
Siemens Healthcare June 2007 - June 2015
Regulatory and Clinical Research Institute 2002 - 2007
Aastrom, BW Medical Group, and Veracel Biotechnologies 1998 - 2002
Dade Behring Ltd.(Baxter, Dade International) 1994 - 1997
Abbott 1990 - 1994
Surgitek 1981 - 1990
Skills
Informatics, Cross-functional Team..., Medical Imaging, Regulatory Affairs, Biomedical Engineering, Medical Devices, HL7, Healthcare Information..., Healthcare, FDA, Clinical Research, Process Improvement, Leadership, Pharmaceutical Industry, Radiology, Clinical Trials, HIPAA, Hardware Diagnostics, Strategy, Cardiology, Program Management
Education
Lake Forest Graduate School of Management
Master of Business Administration (M.B.A.)
Northeastern Illinois University
Master’s Degree, Chemistry
Regulatory and Quality Solutions LLC (R&Q) 2015 - Present
Siemens Healthcare June 2007 - June 2015
Regulatory and Clinical Research Institute 2002 - 2007
Aastrom, BW Medical Group, and Veracel Biotechnologies 1998 - 2002
Dade Behring Ltd.(Baxter, Dade International) 1994 - 1997
Abbott 1990 - 1994
Surgitek 1981 - 1990
Skills
Informatics, Cross-functional Team..., Medical Imaging, Regulatory Affairs, Biomedical Engineering, Medical Devices, HL7, Healthcare Information..., Healthcare, FDA, Clinical Research, Process Improvement, Leadership, Pharmaceutical Industry, Radiology, Clinical Trials, HIPAA, Hardware Diagnostics, Strategy, Cardiology, Program Management
Education
Lake Forest Graduate School of Management
Master of Business Administration (M.B.A.)
Northeastern Illinois University
Master’s Degree, Chemistry
Maria Fagan's Regulatory and Quality Solutions LLC (R&Q) Experience July 2008 - Present
Job President R&Q
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) July 2008 - Present
Medrad July 2006 - July 2008
Medrad January 2005 - July 2006
Medrad April 1996 - January 2005
Skills
Design Control, Medical Devices, Quality Systems, FDA, Product Development, Regulatory Affairs, Quality Assurance, ISO 13485, Quality Management, Quality System, CAPA, Validation, V&V, Cross-functional Team..., Regulatory Submissions, Biotechnology, Lifesciences, Manufacturing, R&D, Commercialization, Lean Manufacturing, Continuous Improvement, ISO, GMP, Design of Experiments, ISO 14971, FMEA, Biomedical Engineering, Design for Manufacturing, Quality Control, Quality Auditing, Six Sigma, Product Launch, Leadership, DMAIC, Root Cause Analysis, SPC, 21 CFR Part 11, Medical Device Directive, Sop, CE marking, Change Control, Minitab, Process Simulation, Manufacturing..., Regulatory Requirements, Supplier Quality, IEC 60601, FDA GMP, GLP
Education
University of Pittsburgh 1985 — 1988
BS, Mechanical Engineering
Regulatory and Quality Solutions LLC (R&Q) July 2008 - Present
Medrad July 2006 - July 2008
Medrad January 2005 - July 2006
Medrad April 1996 - January 2005
Skills
Design Control, Medical Devices, Quality Systems, FDA, Product Development, Regulatory Affairs, Quality Assurance, ISO 13485, Quality Management, Quality System, CAPA, Validation, V&V, Cross-functional Team..., Regulatory Submissions, Biotechnology, Lifesciences, Manufacturing, R&D, Commercialization, Lean Manufacturing, Continuous Improvement, ISO, GMP, Design of Experiments, ISO 14971, FMEA, Biomedical Engineering, Design for Manufacturing, Quality Control, Quality Auditing, Six Sigma, Product Launch, Leadership, DMAIC, Root Cause Analysis, SPC, 21 CFR Part 11, Medical Device Directive, Sop, CE marking, Change Control, Minitab, Process Simulation, Manufacturing..., Regulatory Requirements, Supplier Quality, IEC 60601, FDA GMP, GLP
Education
University of Pittsburgh 1985 — 1988
BS, Mechanical Engineering
Christine Santagate, RAC's Regulatory and Quality Solutions LLC (R&Q) Experience August 2014 - Present
Job Operations Manager at R&Q Solutions
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) August 2014 - Present
University of Massachusetts Lowell January 2015 - Present
STD MED March 2013 - August 2014
STD MED June 2009 - March 2013
BD Medical - Medical Surgical Systems 2008 - 2009
Siemens Healthcare March 2006 - October 2008
Teledyne 2004 - 2006
Avecia June 2001 - March 2004
Skills
Design Control, FDA, Medical Devices, Validation, ISO 13485, CAPA, V&V, GMP, Biomedical Engineering, Quality Assurance, R&D, Product Development, Manufacturing, Cross-functional Team...
Education
Bridgewater State University 2008 — 2009
MS, Management
Assumption College 1997 — 2001
BA, Biology
Regulatory and Quality Solutions LLC (R&Q) August 2014 - Present
University of Massachusetts Lowell January 2015 - Present
STD MED March 2013 - August 2014
STD MED June 2009 - March 2013
BD Medical - Medical Surgical Systems 2008 - 2009
Siemens Healthcare March 2006 - October 2008
Teledyne 2004 - 2006
Avecia June 2001 - March 2004
Skills
Design Control, FDA, Medical Devices, Validation, ISO 13485, CAPA, V&V, GMP, Biomedical Engineering, Quality Assurance, R&D, Product Development, Manufacturing, Cross-functional Team...
Education
Bridgewater State University 2008 — 2009
MS, Management
Assumption College 1997 — 2001
BA, Biology
Adam Smelko's Regulatory and Quality Solutions LLC (R&Q) Experience February 2015 - Present
Job Quality Design Engineer at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) February 2015 - Present
ALung Technologies February 2011 - February 2015
University of Pittsburgh January 2009 - June 2010
Skills
Medical Devices, Biomechanics, Product Development, Design Control, Biomedical Engineering, Stem Cells, Manufacturing, Bioengineering, FDA, Labview, Biomaterials, R&D, LabVIEW
Education
University of Pittsburgh 2006 — 2010
BS, Biomedical Engineering
University of Pittsburgh 2006 — 2010
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Regulatory and Quality Solutions LLC (R&Q) February 2015 - Present
ALung Technologies February 2011 - February 2015
University of Pittsburgh January 2009 - June 2010
Skills
Medical Devices, Biomechanics, Product Development, Design Control, Biomedical Engineering, Stem Cells, Manufacturing, Bioengineering, FDA, Labview, Biomaterials, R&D, LabVIEW
Education
University of Pittsburgh 2006 — 2010
BS, Biomedical Engineering
University of Pittsburgh 2006 — 2010
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Jovan Bonds's Regulatory and Quality Solutions LLC (R&Q) Experience October 2014 - Present
Job Senior Consultant at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) October 2014 - Present
Maetrics, LLC August 2013 - Present
Roche Diagnostics January 2008 - August 2013
Roche Diagnostics May 2006 - January 2008
Disetronic Medical Systems January 2004 - May 2006
Roche Diagnostics December 2002 - January 2004
Indiana Department of Workforce Development May 1997 - December 2002
Skills
Medical Devices, Diabetes, FDA, Training, SAP, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Customer Service, GMP, Management, Cross-functional Team..., Computer System..., Biotechnology, Microsoft Excel, Regulatory Affairs, Human Resources, Validation, Troubleshooting, Software Documentation, Hardware Diagnostics, Microsoft Word, Complaince, Diabetes Care, Coagulation, Technical Writing, Compass, Quality Consulting, MDRs, Privacy Policies, Privacy Compliance, Privacy Regulations, Privacy Act, Data Privacy, Security Management, Supplemental MDRs, Remediation, Process Improvement, EtQ Reliance
Education
Franklin College 1999 — 2002
B.A., Political Science, Psychology and Law, 3.0 GPA
Vincennes University 1996 — 1999
Pre-Law
Regulatory and Quality Solutions LLC (R&Q) October 2014 - Present
Maetrics, LLC August 2013 - Present
Roche Diagnostics January 2008 - August 2013
Roche Diagnostics May 2006 - January 2008
Disetronic Medical Systems January 2004 - May 2006
Roche Diagnostics December 2002 - January 2004
Indiana Department of Workforce Development May 1997 - December 2002
Skills
Medical Devices, Diabetes, FDA, Training, SAP, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Customer Service, GMP, Management, Cross-functional Team..., Computer System..., Biotechnology, Microsoft Excel, Regulatory Affairs, Human Resources, Validation, Troubleshooting, Software Documentation, Hardware Diagnostics, Microsoft Word, Complaince, Diabetes Care, Coagulation, Technical Writing, Compass, Quality Consulting, MDRs, Privacy Policies, Privacy Compliance, Privacy Regulations, Privacy Act, Data Privacy, Security Management, Supplemental MDRs, Remediation, Process Improvement, EtQ Reliance
Education
Franklin College 1999 — 2002
B.A., Political Science, Psychology and Law, 3.0 GPA
Vincennes University 1996 — 1999
Pre-Law
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY