R&Q Company
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R&Q Employees
Employee
Years
Job
Industry
Donald Whitman Donald Whitman's R&Q Experience May 2014 - September 2014
Job Remediation Complaints/Reporting Specialist at EG Life Sciences
Industry Medical Devices
Experience
EG Life Sciences June 2015 - Present
NovusLife, LLC September 2014 - April 2015
R&Q May 2014 - September 2014
Maetrics, LLC September 2012 - May 2014
Medtronic September 2011 - June 2012
Nassau County School Board August 2006 - June 2010
Hampton Inn and Suites - Pigeon Forge July 2005 - April 2006
Nassau County School Board August 2003 - June 2005
Hampton Inn & Suites 2002 - 2003
Skills
Complaints, Product Complaints, Complaint Investigations, MDR, Remediation, Trackwise, SAP, Compliance, Complaint Management, CAPA, FDA, Quality System, Validation, GMP, ISO 13485, 21 CFR Part 11, Medical Devices, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Software Documentation, Quality Management, V&V
Education
University of North Florida 1998 — 2003
Bachelor of Arts (B.A.), Elementary Education and Teaching, 3.5
Florida State College at Jacksonville 1999 — 2001
Associate of Arts (A.A.), Elementary Education and Teaching, 4.0
EG Life Sciences June 2015 - Present
NovusLife, LLC September 2014 - April 2015
R&Q May 2014 - September 2014
Maetrics, LLC September 2012 - May 2014
Medtronic September 2011 - June 2012
Nassau County School Board August 2006 - June 2010
Hampton Inn and Suites - Pigeon Forge July 2005 - April 2006
Nassau County School Board August 2003 - June 2005
Hampton Inn & Suites 2002 - 2003
Skills
Complaints, Product Complaints, Complaint Investigations, MDR, Remediation, Trackwise, SAP, Compliance, Complaint Management, CAPA, FDA, Quality System, Validation, GMP, ISO 13485, 21 CFR Part 11, Medical Devices, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Software Documentation, Quality Management, V&V
Education
University of North Florida 1998 — 2003
Bachelor of Arts (B.A.), Elementary Education and Teaching, 3.5
Florida State College at Jacksonville 1999 — 2001
Associate of Arts (A.A.), Elementary Education and Teaching, 4.0
Sherri Hall Sherri Hall's R&Q Experience June 2011 - Present
Job Regulatory and Quality Engineer at R&Q Solutions
Industry Medical Devices
Experience
R&Q June 2011 - Present
Cohera Medical, Inc. May 2009 - May 2010
S. R. Little Laboratories August 2008 - May 2009
Barrington Medical Imaging, LLC June 2008 - January 2009
Skills
GLP, QSR, Medical Device Product..., Medical Devices, Product Development, Biomedical Engineering, Regulatory Affairs, Quality Auditing, FDA, Clinical Research, Quality System, ISO 13485, V&V, CAPA, Validation
Education
The Johns Hopkins University 2010 — 2011
MSE, Bioengineering Innovation and Design
University of Pittsburgh 2006 — 2010
Bachelor of Science, Bioengineering
R&Q June 2011 - Present
Cohera Medical, Inc. May 2009 - May 2010
S. R. Little Laboratories August 2008 - May 2009
Barrington Medical Imaging, LLC June 2008 - January 2009
Skills
GLP, QSR, Medical Device Product..., Medical Devices, Product Development, Biomedical Engineering, Regulatory Affairs, Quality Auditing, FDA, Clinical Research, Quality System, ISO 13485, V&V, CAPA, Validation
Education
The Johns Hopkins University 2010 — 2011
MSE, Bioengineering Innovation and Design
University of Pittsburgh 2006 — 2010
Bachelor of Science, Bioengineering
Ryan Kasun Ryan Kasun's R&Q Experience June 2008 - Present
Job Project Engineer, PMP
Industry Medical Devices
Experience
R&Q June 2008 - Present
Medrad 2007 - 2007
The Pennsylvania State University September 2005 - August 2006
Skills
Project Management, Quality Systems, Quality Auditing, Policy Writing, Medical Devices, Design Control, FDA, Manufacturing, ISO 13485, Internal Audit, Quality System, Training, Supplier Quality, Root Cause Analysis, FMEA, Biomedical Engineering, ISO, V&V, ISO 14971, Design of Experiments, Quality Assurance, SPC, CAPA, Quality Management, Quality Control, Validation, Testing, CE marking, GMP, 21 CFR, Regulatory Affairs, IEC 60601, FDA GMP, DMAIC, Process Capability, Medical Device Directive
Education
Penn State University 2004 — 2008
BS, BioEngineering
Franklin Regional High School 2000 — 2004
R&Q June 2008 - Present
Medrad 2007 - 2007
The Pennsylvania State University September 2005 - August 2006
Skills
Project Management, Quality Systems, Quality Auditing, Policy Writing, Medical Devices, Design Control, FDA, Manufacturing, ISO 13485, Internal Audit, Quality System, Training, Supplier Quality, Root Cause Analysis, FMEA, Biomedical Engineering, ISO, V&V, ISO 14971, Design of Experiments, Quality Assurance, SPC, CAPA, Quality Management, Quality Control, Validation, Testing, CE marking, GMP, 21 CFR, Regulatory Affairs, IEC 60601, FDA GMP, DMAIC, Process Capability, Medical Device Directive
Education
Penn State University 2004 — 2008
BS, BioEngineering
Franklin Regional High School 2000 — 2004
Lisa Casavant's R&Q Experience 2008 - Present
Job Cofounder and VP of R&Q
Industry Medical Devices
Experience
R&Q 2008 - Present
MEDRAD (Acquired by Bayer Healthcare) 2004 - 2008
Tyco Healthcare Retail Group 2001 - 2003
Eveready Battery Company (Energizer) 1998 - 2001
Skills
Regulatory Affairs, Quality Assurance, Medical Devices, Leadership, ISO 13485, Design Control, FDA, Quality System, CAPA, V&V, Biomedical Engineering, Validation, Cross-functional Team..., Biotechnology, Manufacturing, Product Development, Six Sigma, FMEA, Lean Manufacturing, Strategy, GMP, Risk Management, Quality Auditing, Regulatory Submissions, Root Cause Analysis, Quality Management, Process Improvement, Commercialization, Continuous Improvement
Education
University of Delaware 1995 — 1997
MS, Mechanical Engineering
West Virginia University 1991 — 1995
BS, Mechanical Engineering
R&Q 2008 - Present
MEDRAD (Acquired by Bayer Healthcare) 2004 - 2008
Tyco Healthcare Retail Group 2001 - 2003
Eveready Battery Company (Energizer) 1998 - 2001
Skills
Regulatory Affairs, Quality Assurance, Medical Devices, Leadership, ISO 13485, Design Control, FDA, Quality System, CAPA, V&V, Biomedical Engineering, Validation, Cross-functional Team..., Biotechnology, Manufacturing, Product Development, Six Sigma, FMEA, Lean Manufacturing, Strategy, GMP, Risk Management, Quality Auditing, Regulatory Submissions, Root Cause Analysis, Quality Management, Process Improvement, Commercialization, Continuous Improvement
Education
University of Delaware 1995 — 1997
MS, Mechanical Engineering
West Virginia University 1991 — 1995
BS, Mechanical Engineering
Theresa Miles Theresa Miles's R&Q Experience February 2014 - Present
Job Director of Client Solutions at R&Q
Industry Medical Devices
Experience
R&Q February 2014 - Present
R&Q May 2013 - February 2014
Regulatory and Quality Solutions February 2011 - May 2013
Medrad April 2005 - March 2011
Helomics (formerly Precision Therapeutics) 2002 - 2005
Skills
FDA, Quality System, Cross-functional Team..., CAPA, Medical Devices, Quality Assurance, ISO 13485, Design Control, Regulatory Affairs, Validation, V&V, Quality Auditing, Commercialization, Six Sigma, Product Development, GMP, Biomedical Engineering, Biotechnology, Product Launch, Leadership, Hardware Diagnostics, Quality Control, R&D, Medical Device Directive, Pharmaceutical Industry, Capital Equipment, Clinical Research, Clinical Trials, ISO 14971, Supplier Quality, Lifesciences, FMEA, Market Development, Management, Root Cause Analysis, Sop, FDA GMP, SPC, 21 CFR, Quality Management, Regulatory Submissions, Medical Imaging, Process Improvement
Education
St. Francis University 1989 — 1993
BS, Biology
R&Q February 2014 - Present
R&Q May 2013 - February 2014
Regulatory and Quality Solutions February 2011 - May 2013
Medrad April 2005 - March 2011
Helomics (formerly Precision Therapeutics) 2002 - 2005
Skills
FDA, Quality System, Cross-functional Team..., CAPA, Medical Devices, Quality Assurance, ISO 13485, Design Control, Regulatory Affairs, Validation, V&V, Quality Auditing, Commercialization, Six Sigma, Product Development, GMP, Biomedical Engineering, Biotechnology, Product Launch, Leadership, Hardware Diagnostics, Quality Control, R&D, Medical Device Directive, Pharmaceutical Industry, Capital Equipment, Clinical Research, Clinical Trials, ISO 14971, Supplier Quality, Lifesciences, FMEA, Market Development, Management, Root Cause Analysis, Sop, FDA GMP, SPC, 21 CFR, Quality Management, Regulatory Submissions, Medical Imaging, Process Improvement
Education
St. Francis University 1989 — 1993
BS, Biology
Dino Mavromatis Dino Mavromatis's R&Q Experience February 2013 - Present
Job Medical Devices Professional
Industry Medical Devices
Experience
R&Q February 2013 - Present
DM Inc. June 2011 - January 2013
Philips Healthcare November 2010 - May 2011
Philips Healthcare March 2009 - October 2010
Philips Healthcare October 2007 - March 2009
Philips Healthcare July 2005 - October 2007
Philips Healthcare June 2001 - July 2005
Marconi Medical Systems January 2000 - May 2001
Picker International March 1997 - December 1999
Pressco Technology April 1995 - March 1997
Skills
Global team leadership, Systems Engineering, Project Management, Portfolio Management, Large Scale Reuse via..., Process Improvement, Concurrent Development..., Software Engineering..., CMMI, Six Sigma, Design for Reliability, FDA GMP, EU Medical Device..., Design Controls, PMBOK, Change Management, Strategy, Medical Devices, Design Control, Engineering, Cross-functional Team..., CAPA, Engineering Management, V&V, FDA, Medical Imaging, ISO 14971, Radiology, Integration, ISO 13485, R&D, Reliability Engineering, Biomedical Engineering, Digital Imaging, Product Development, Quality System, Testing, Validation, Software Engineering, Program Management, System Architecture, Manufacturing, Requirements Analysis, DMAIC, PACS, FMEA, Simulations, Product Launch, Design of Experiments, Quality Management
Education
Harvey Mudd College 1978 — 1982
Bachelor of Science (B.S.), Electrical and Electronics Engineering
USC
R&Q February 2013 - Present
DM Inc. June 2011 - January 2013
Philips Healthcare November 2010 - May 2011
Philips Healthcare March 2009 - October 2010
Philips Healthcare October 2007 - March 2009
Philips Healthcare July 2005 - October 2007
Philips Healthcare June 2001 - July 2005
Marconi Medical Systems January 2000 - May 2001
Picker International March 1997 - December 1999
Pressco Technology April 1995 - March 1997
Skills
Global team leadership, Systems Engineering, Project Management, Portfolio Management, Large Scale Reuse via..., Process Improvement, Concurrent Development..., Software Engineering..., CMMI, Six Sigma, Design for Reliability, FDA GMP, EU Medical Device..., Design Controls, PMBOK, Change Management, Strategy, Medical Devices, Design Control, Engineering, Cross-functional Team..., CAPA, Engineering Management, V&V, FDA, Medical Imaging, ISO 14971, Radiology, Integration, ISO 13485, R&D, Reliability Engineering, Biomedical Engineering, Digital Imaging, Product Development, Quality System, Testing, Validation, Software Engineering, Program Management, System Architecture, Manufacturing, Requirements Analysis, DMAIC, PACS, FMEA, Simulations, Product Launch, Design of Experiments, Quality Management
Education
Harvey Mudd College 1978 — 1982
Bachelor of Science (B.S.), Electrical and Electronics Engineering
USC
Peter Sobotta Peter Sobotta's R&Q Experience June 2014 - September 2014
Job Sr. Compliance Consultant at Validant
Industry Medical Devices
Experience
Validant September 2014 - Present
R&Q June 2014 - September 2014
Maetrics, LLC January 2014 - June 2014
Hospira January 2012 - January 2014
Ethicon Endo-Surgery April 2010 - January 2012
Mercy Mt. Airy Hospital August 2009 - December 2011
Riverhills Healthcare, Inc. October 2008 - August 2009
Innovex April 2005 - November 2007
Skills
Clinical Research, Cardiology, Healthcare, Medical Devices, Oncology, Hospitals, Clinical Trials, Surgery, Neurology, Medicine, Managed Care, Critical Care, Diabetes, Patient Safety, FDA, Regulatory Affairs, Pharmaceutical Industry, ISO 13485, CAPA, SOP, GCP
Education
Concordia University-Wisconsin 2002 — 2005
BSN, Nursing
Validant September 2014 - Present
R&Q June 2014 - September 2014
Maetrics, LLC January 2014 - June 2014
Hospira January 2012 - January 2014
Ethicon Endo-Surgery April 2010 - January 2012
Mercy Mt. Airy Hospital August 2009 - December 2011
Riverhills Healthcare, Inc. October 2008 - August 2009
Innovex April 2005 - November 2007
Skills
Clinical Research, Cardiology, Healthcare, Medical Devices, Oncology, Hospitals, Clinical Trials, Surgery, Neurology, Medicine, Managed Care, Critical Care, Diabetes, Patient Safety, FDA, Regulatory Affairs, Pharmaceutical Industry, ISO 13485, CAPA, SOP, GCP
Education
Concordia University-Wisconsin 2002 — 2005
BSN, Nursing
Christy Keenan Christy Keenan's R&Q Experience February 2014 - Present
Job Payroll Manager at R&Q
Industry Medical Devices
Experience
R&Q February 2014 - Present
KPMG US September 2004 - March 2011
KPMG US March 2002 - September 2004
KPMG US September 2000 - March 2002
Skills
Payroll, Tax
Education
University of Pittsburgh 1996 — 2000
Bachelor of Arts (BA), Accounting and Computer Science
University of Pittsburgh-Johnstown 1996 — 2000
Bachelor of Arts (B.A.), Accounting
R&Q February 2014 - Present
KPMG US September 2004 - March 2011
KPMG US March 2002 - September 2004
KPMG US September 2000 - March 2002
Skills
Payroll, Tax
Education
University of Pittsburgh 1996 — 2000
Bachelor of Arts (BA), Accounting and Computer Science
University of Pittsburgh-Johnstown 1996 — 2000
Bachelor of Arts (B.A.), Accounting
Kimberly Platt Kimberly Platt's R&Q Experience July 2014 - Present
Job Manager of Pennsylvania Operations at R&Q
Industry Medical Devices
Experience
R&Q July 2014 - Present
Regulatory and Quality Solutions LLC January 2012 - June 2014
MEDRAD, Inc. January 2005 - January 2012
MEDRAD, Inc. July 2000 - December 2004
Allegheny General Hospital August 1991 - December 2001
Skills
Post-Market..., Report Writing, ARRT Registered..., Advanced Certifications..., Medical Devices, Interventional Radiology, Radiology, FDA, CAPA, Vascular, Medical Imaging, Regulatory Affairs, Cath Lab, PACS, Quality System, Quality Assurance, Clinical Research, Regulatory Requirements, Quality Control, MRI, Healthcare, Computed Tomography, 21 CFR Part 11, Cross-functional Team..., Field Service, Product Launch
Education
Allegheny General Hospital 1988 — 1990
Associate of Science (A.S.), Radiologic Technology/Science - Radiographer
Robert Morris University
Bachelor of Science (B.S.), Business Administration and Health Services Management
R&Q July 2014 - Present
Regulatory and Quality Solutions LLC January 2012 - June 2014
MEDRAD, Inc. January 2005 - January 2012
MEDRAD, Inc. July 2000 - December 2004
Allegheny General Hospital August 1991 - December 2001
Skills
Post-Market..., Report Writing, ARRT Registered..., Advanced Certifications..., Medical Devices, Interventional Radiology, Radiology, FDA, CAPA, Vascular, Medical Imaging, Regulatory Affairs, Cath Lab, PACS, Quality System, Quality Assurance, Clinical Research, Regulatory Requirements, Quality Control, MRI, Healthcare, Computed Tomography, 21 CFR Part 11, Cross-functional Team..., Field Service, Product Launch
Education
Allegheny General Hospital 1988 — 1990
Associate of Science (A.S.), Radiologic Technology/Science - Radiographer
Robert Morris University
Bachelor of Science (B.S.), Business Administration and Health Services Management
Suyesh Acharya's R&Q Experience June 2013 - May 2015
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
Jennifer (Yeager) Noll Jennifer (Yeager) Noll's R&Q Experience May 2014 - July 2014
Job Regulatory Compliance Specialist at ChemADVISOR, Inc.
Industry Biotechnology
Experience
ChemADVISOR, Inc. January 2015 - Present
R&Q May 2014 - July 2014
Education
University of Pittsburgh 2010 — 2014
Bachelor's Degree, Bioengineering
ChemADVISOR, Inc. January 2015 - Present
R&Q May 2014 - July 2014
Education
University of Pittsburgh 2010 — 2014
Bachelor's Degree, Bioengineering
Ankitha Rao Ankitha Rao's R&Q Experience February 2014 - July 2015
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
Maria Fattore's R&Q Experience February 2014 - February 2015
Job Independent Consultant
Industry Health, Wellness and Fitness
Experience
R&Q February 2014 - February 2015
Self Employed 2015 - 2015
ReGear Life Sciences June 2008 - December 2013
BodyMedia April 2003 - May 2008
BodyMedia March 2001 - March 2003
Skills
Quality Assurance, Quality Management, Quality System, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Product Marketing, Product Launch, Product Development, Product Management, Cross-functional Team..., Manufacturing, Customer Support, FDA, CRM, Supply Chain Management, Management, ERP, ISO 13485, Supply Chain, CAPA, Project Management, Process Improvement, Marketing Strategy, Strategic Planning
Education
Robert Morris University 1996 — 2000
BSBA, Finance/Economics
Hopewell
Hopewell
R&Q February 2014 - February 2015
Self Employed 2015 - 2015
ReGear Life Sciences June 2008 - December 2013
BodyMedia April 2003 - May 2008
BodyMedia March 2001 - March 2003
Skills
Quality Assurance, Quality Management, Quality System, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Product Marketing, Product Launch, Product Development, Product Management, Cross-functional Team..., Manufacturing, Customer Support, FDA, CRM, Supply Chain Management, Management, ERP, ISO 13485, Supply Chain, CAPA, Project Management, Process Improvement, Marketing Strategy, Strategic Planning
Education
Robert Morris University 1996 — 2000
BSBA, Finance/Economics
Hopewell
Hopewell
Jillian Walker Jillian Walker's R&Q Experience June 2012 - November 2014
Job Senior Regulatory Affairs Specialist at NanoString Technologies, Inc.
Industry Medical Devices
Experience
NanoString Technologies, Inc. December 2014 - Present
R&Q June 2012 - November 2014
Blue Belt Technologies September 2011 - June 2012
ALung Technologies May 2011 - September 2011
Cohera Medical Inc May 2010 - May 2011
Villanova University September 2009 - May 2010
Skills
FDA, Medical Devices, Quality System, Design Control, Regulatory Affairs, ISO 13485, Regulatory Submissions, Project Management, Consulting, Biomedical Engineering, Regulatory Documentation, Medical Device Software..., Regulatory Strategy..., Product Complaints, MDR, Regulatory Requirements, Regulations, Regulatory Compliance, Regulatory Guidelines, Regulatory Reporting, Global Regulatory..., Medical Device Directive, Process Consulting, Quality Assurance, Quality Control, Quality Improvement
Education
Carnegie Mellon University 2010 — 2012
Master's, Biotechnology & Management
Villanova University 2006 — 2010
Bachelors, Chemical Engineering
NanoString Technologies, Inc. December 2014 - Present
R&Q June 2012 - November 2014
Blue Belt Technologies September 2011 - June 2012
ALung Technologies May 2011 - September 2011
Cohera Medical Inc May 2010 - May 2011
Villanova University September 2009 - May 2010
Skills
FDA, Medical Devices, Quality System, Design Control, Regulatory Affairs, ISO 13485, Regulatory Submissions, Project Management, Consulting, Biomedical Engineering, Regulatory Documentation, Medical Device Software..., Regulatory Strategy..., Product Complaints, MDR, Regulatory Requirements, Regulations, Regulatory Compliance, Regulatory Guidelines, Regulatory Reporting, Global Regulatory..., Medical Device Directive, Process Consulting, Quality Assurance, Quality Control, Quality Improvement
Education
Carnegie Mellon University 2010 — 2012
Master's, Biotechnology & Management
Villanova University 2006 — 2010
Bachelors, Chemical Engineering
Julie Rodgers's R&Q Experience December 2013 - Present
Job Manager of Financial Analysis at R&Q
Industry Medical Devices
Experience
R&Q December 2013 - Present
The Longboat Group June 2012 - November 2013
MEDRAD, INC February 2007 - June 2012
Medrad September 2006 - February 2007
Medrad November 2003 - September 2006
KPMG September 2000 - November 2003
Skills
Process Improvement, Auditing, Six Sigma, SAP, Manufacturing, Business Process..., Financial Analysis, Strategic Planning, Forecasting, Financial Reporting, Accounting, Finance, Corporate Finance, Sarbanes-Oxley Act, Managerial Finance, Financial Accounting, Strategic Financial..., Financial Modeling, Internal Audit, Internal Controls, SEC filings, Cost Accounting, Tax, Financial Planning
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 2004 — 2007
MBA
Bethany College 1996 — 2000
BA, Accounting
R&Q December 2013 - Present
The Longboat Group June 2012 - November 2013
MEDRAD, INC February 2007 - June 2012
Medrad September 2006 - February 2007
Medrad November 2003 - September 2006
KPMG September 2000 - November 2003
Skills
Process Improvement, Auditing, Six Sigma, SAP, Manufacturing, Business Process..., Financial Analysis, Strategic Planning, Forecasting, Financial Reporting, Accounting, Finance, Corporate Finance, Sarbanes-Oxley Act, Managerial Finance, Financial Accounting, Strategic Financial..., Financial Modeling, Internal Audit, Internal Controls, SEC filings, Cost Accounting, Tax, Financial Planning
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 2004 — 2007
MBA
Bethany College 1996 — 2000
BA, Accounting
Julia Wnek's R&Q Experience March 2012 - January 2015
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
Mariana Pulvirenti's R&Q Experience September 2008 - Present
Job IT Analyst, programmer, Web Designer
Industry Computer Software
Experience
RQ September 2008 - Present
HEC Montreal June 2008 - September 2008
Celulosa Moldeada SA January 1992 - March 2001
Education
HEC Montréal 2005 — 2008
RQ September 2008 - Present
HEC Montreal June 2008 - September 2008
Celulosa Moldeada SA January 1992 - March 2001
Education
HEC Montréal 2005 — 2008
Lori Smith-Sakalousky's R&Q Experience March 2013 - January 2015
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
Casey Cramer's R&Q Experience February 2013 - July 2015
Job Regulatory Specialist at Sparton Medical Systems, Inc.
Industry Medical Devices
Experience
Sparton Medical Systems, Inc. August 2015 - Present
R&Q February 2013 - July 2015
US Army September 2009 - February 2013
General Motors October 2005 - June 2009
Skills
Lean Manufacturing, Engineering, Root Cause Analysis, Continuous Improvement, Six Sigma, Manufacturing..., Minitab, Manufacturing..., Quality Management, Mechanical Engineering, Manufacturing, Process Improvement, Quality Assurance, Testing, Quality System, Quality Control, Medical Devices
Education
Kettering University 2005 — 2009
Bachelor of Science (BS), Mechanical Engineering, Management Minor
Sparton Medical Systems, Inc. August 2015 - Present
R&Q February 2013 - July 2015
US Army September 2009 - February 2013
General Motors October 2005 - June 2009
Skills
Lean Manufacturing, Engineering, Root Cause Analysis, Continuous Improvement, Six Sigma, Manufacturing..., Minitab, Manufacturing..., Quality Management, Mechanical Engineering, Manufacturing, Process Improvement, Quality Assurance, Testing, Quality System, Quality Control, Medical Devices
Education
Kettering University 2005 — 2009
Bachelor of Science (BS), Mechanical Engineering, Management Minor
Matthew Burger's R&Q Experience July 2014 - Present
Job Manager of Pennsylvania Operations at Regulatory and Quality Solutions
Industry Medical Devices
Experience
R&Q July 2014 - Present
R&Q November 2012 - Present
Philips Respironics December 2011 - November 2012
Philips Respironics November 2006 - November 2011
Nasal product lines November 2006 - December 2010
Captive Plastics November 2004 - October 2006
Captive Plastics Inc November 2004 - October 2006
Paradigm Packaging May 2004 - November 2004
Paradigm Packaging May 2004 - November 2004
Penn State, The Behrend College March 2004 - April 2004
Skills
Manufacturing, FDA, Injection Molding, CAPA, Medical Devices, Engineering, ISO 13485, Design Control, Quality System, Training, Moldflow, ANSYS, ISO 14971, Minitab, Blow Molding, Plastics, 21 CFR, ISO, CE marking, Molding, Validation, Product Development, Design for Manufacturing, Quality Control, V&V, Design of Experiments, FMEA, DMAIC, Supplier Quality, Labview, Root Cause Analysis, Pro Engineer, Testing, Extrusion, Quality Assurance, Manufacturing..., Iso 9000, FDA GMP
Education
Point Park University 2010 — 2012
MSEM (Masters of Science - Engineering Management), Engineering
Penn State University 2000 — 2004
PLET, Engineering
Pennsylvania State University, The Behrend College 2000 — 2004
Baccalaureate, Plastic Engineering and Technology
R&Q July 2014 - Present
R&Q November 2012 - Present
Philips Respironics December 2011 - November 2012
Philips Respironics November 2006 - November 2011
Nasal product lines November 2006 - December 2010
Captive Plastics November 2004 - October 2006
Captive Plastics Inc November 2004 - October 2006
Paradigm Packaging May 2004 - November 2004
Paradigm Packaging May 2004 - November 2004
Penn State, The Behrend College March 2004 - April 2004
Skills
Manufacturing, FDA, Injection Molding, CAPA, Medical Devices, Engineering, ISO 13485, Design Control, Quality System, Training, Moldflow, ANSYS, ISO 14971, Minitab, Blow Molding, Plastics, 21 CFR, ISO, CE marking, Molding, Validation, Product Development, Design for Manufacturing, Quality Control, V&V, Design of Experiments, FMEA, DMAIC, Supplier Quality, Labview, Root Cause Analysis, Pro Engineer, Testing, Extrusion, Quality Assurance, Manufacturing..., Iso 9000, FDA GMP
Education
Point Park University 2010 — 2012
MSEM (Masters of Science - Engineering Management), Engineering
Penn State University 2000 — 2004
PLET, Engineering
Pennsylvania State University, The Behrend College 2000 — 2004
Baccalaureate, Plastic Engineering and Technology
Prophète Louis's R&Q Experience November 2006 - January 2013
Job Conseiller en développement des compétences chez Revenu Québec
Industry Human Resources
Experience
Revenu Québec January 2013 - Present
RQ November 2006 - January 2013
Clarica, Desjardins Sécurité Financière November 2004 - November 2006
Skills
Excellente..., Excellente..., Excellente connaissance..., Excellente connaissance..., Excellente connaissance..., Beaucoup d'expérience..., Langues parlées et..., Gestion de dossier, Gestion de risque
Education
École des sciences de la gestion (ESG UQAM) 2007 — 2012
Baccalauréat en Science de la Gestion, Ressources Humaines/Droit du travail/Comptabilité, Terminé
UQAM 2011 — 2012
Cetificat en Gestion des ressources Humaines, Ressources Humaines, Réussi
École des sciences de la gestion (ESG UQAM) 2009 — 2012
Certificat en Comptabilité, Comptabilité, Réussi
Université du Québec à Montréal 2007 — 2008
Certificat, Droit Social et du Travail, Réussi
Saje montréal Metro 2006 — 2006
Attestation d’étude professionnelle en Lancement d'entreprise, Démarrage d'entreprise, réussi
Cegep du vieux 2002 — 2004
DEC Administration Option Service Financiers, Finance et Assurance, Réussi
Ahuntsic 1998 — 2002
DEC en Génie Électrique Option : Télécommunication, Telecommunications Engineering, Réussi
Revenu Québec January 2013 - Present
RQ November 2006 - January 2013
Clarica, Desjardins Sécurité Financière November 2004 - November 2006
Skills
Excellente..., Excellente..., Excellente connaissance..., Excellente connaissance..., Excellente connaissance..., Beaucoup d'expérience..., Langues parlées et..., Gestion de dossier, Gestion de risque
Education
École des sciences de la gestion (ESG UQAM) 2007 — 2012
Baccalauréat en Science de la Gestion, Ressources Humaines/Droit du travail/Comptabilité, Terminé
UQAM 2011 — 2012
Cetificat en Gestion des ressources Humaines, Ressources Humaines, Réussi
École des sciences de la gestion (ESG UQAM) 2009 — 2012
Certificat en Comptabilité, Comptabilité, Réussi
Université du Québec à Montréal 2007 — 2008
Certificat, Droit Social et du Travail, Réussi
Saje montréal Metro 2006 — 2006
Attestation d’étude professionnelle en Lancement d'entreprise, Démarrage d'entreprise, réussi
Cegep du vieux 2002 — 2004
DEC Administration Option Service Financiers, Finance et Assurance, Réussi
Ahuntsic 1998 — 2002
DEC en Génie Électrique Option : Télécommunication, Telecommunications Engineering, Réussi
Mihaela Bal, CPA, CGA's R&Q Experience 2009 - 2011
Job Agente de la gestion financière
Industry Food Production
Experience
RQ 2009 - 2011
Education
HEC Montréal 2009 — 2009
Attestation, CGA - micro programme
HEC Montréal 2008 — 2009
Certificat, Accès aux professions comptables
RQ 2009 - 2011
Education
HEC Montréal 2009 — 2009
Attestation, CGA - micro programme
HEC Montréal 2008 — 2009
Certificat, Accès aux professions comptables
Cassandra Rummel's R&Q Experience July 2008 - Present
Job Senior Design Assurance Engineer
Industry Medical Devices
Experience
R&Q July 2008 - Present
MEDRAD, Inc. May 2007 - April 2008
MEDRAD, Inc. February 2006 - May 2007
Cummins Inc. June 2004 - February 2006
Skills
Writing Verification..., Developing Usability..., Extensive Experience..., Design Control, Validation, CAPA, Product Development, ISO 13485, FDA, V&V, Medical Devices, FMEA, Biomedical Engineering, Quality System
Education
Pennsylvania State University-Erie Campus 2000 — 2004
Bachelor of Science, Mechanical Engineering
R&Q July 2008 - Present
MEDRAD, Inc. May 2007 - April 2008
MEDRAD, Inc. February 2006 - May 2007
Cummins Inc. June 2004 - February 2006
Skills
Writing Verification..., Developing Usability..., Extensive Experience..., Design Control, Validation, CAPA, Product Development, ISO 13485, FDA, V&V, Medical Devices, FMEA, Biomedical Engineering, Quality System
Education
Pennsylvania State University-Erie Campus 2000 — 2004
Bachelor of Science, Mechanical Engineering
Daria Brown's R&Q Experience August 2010 - Present
Job Senior Regulatory Engineer at R&Q
Industry Medical Devices
Experience
R&Q August 2010 - Present
Skills
Design Control, Regulatory Affairs, Quality System, Medical Devices, ISO 13485
Education
University of Pittsburgh
Master of Engineering (MEng), Mechanical and Biomedical Engineering
R&Q August 2010 - Present
Skills
Design Control, Regulatory Affairs, Quality System, Medical Devices, ISO 13485
Education
University of Pittsburgh
Master of Engineering (MEng), Mechanical and Biomedical Engineering