Reglera Company
Industry: Management consulting company
DescriptionHeadquarters: Wheat Ridge, CO Founded: 1999 Parent organization: Dohmen Investment Group, LLC
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Reglera Employees
Employee
Years
Job
Industry
Eric Kjellesvig Eric Kjellesvig's Reglera Experience October 2012 - June 2013
Job RA/QA Project Director at RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.)
Industry Medical Devices
Experience
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2014 - Present
Skyline Medical Inc. September 2013 - May 2014
Reglera October 2012 - June 2013
Zimmer Spine June 2007 - April 2012
Zimmer Spine February 2003 - June 2007
Beckman Coulter May 2000 - February 2003
Beckman Coulter August 1991 - May 2000
Skills
Risk Management, Medical Devices, FDA, CAPA, Supplier Development, Product Specification, Regulatory Affairs, MRB, Quality Control, V&V, Quality System, Validation, ISO 13485, ISO, GMP, Quality Systems Design, Sop, FMEA, Quality Assurance, IQ, Manufacturing, Biotechnology, ISO 14971, Product Development, Design Control, 21 CFR Part 11, R&D, Quality Auditing, Testing, Design of Experiments, Sterilization, Software Documentation, Design for Manufacturing, Change Control, 21 CFR, SOP
Education
University of Minnesota-Twin Cities 1982 — 1988
B.S., Microbiology
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2014 - Present
Skyline Medical Inc. September 2013 - May 2014
Reglera October 2012 - June 2013
Zimmer Spine June 2007 - April 2012
Zimmer Spine February 2003 - June 2007
Beckman Coulter May 2000 - February 2003
Beckman Coulter August 1991 - May 2000
Skills
Risk Management, Medical Devices, FDA, CAPA, Supplier Development, Product Specification, Regulatory Affairs, MRB, Quality Control, V&V, Quality System, Validation, ISO 13485, ISO, GMP, Quality Systems Design, Sop, FMEA, Quality Assurance, IQ, Manufacturing, Biotechnology, ISO 14971, Product Development, Design Control, 21 CFR Part 11, R&D, Quality Auditing, Testing, Design of Experiments, Sterilization, Software Documentation, Design for Manufacturing, Change Control, 21 CFR, SOP
Education
University of Minnesota-Twin Cities 1982 — 1988
B.S., Microbiology
Candida Williams Candida Williams's Reglera Experience October 2008 - November 2010
Job Project Manager
Industry Computer Software
Experience
Harris Computer Systems October 2014 - Present
Syncroness November 2010 - October 2014
Reglera October 2008 - November 2010
Carefree of Colorado August 2006 - October 2008
Hart InterCivic February 2001 - August 2006
All American Semiconductor 1998 - 2001
Skills
Process Improvement, Cross-functional Team..., Microsoft Excel, Project Management, Customer Service, Microsoft Office, Event Planning, Account Management, Budgets, Project Planning, Salesforce.com, Continuous Improvement, PowerPoint, Lean Manufacturing, Vendor Management, Medical Devices, Management, Manufacturing, Product Development, Procurement, Leadership, Operations Management, Program Management, Quality Assurance, Software Documentation, Training
Education
Metropolitan State College of Denver 1998 — 2004
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Harris Computer Systems October 2014 - Present
Syncroness November 2010 - October 2014
Reglera October 2008 - November 2010
Carefree of Colorado August 2006 - October 2008
Hart InterCivic February 2001 - August 2006
All American Semiconductor 1998 - 2001
Skills
Process Improvement, Cross-functional Team..., Microsoft Excel, Project Management, Customer Service, Microsoft Office, Event Planning, Account Management, Budgets, Project Planning, Salesforce.com, Continuous Improvement, PowerPoint, Lean Manufacturing, Vendor Management, Medical Devices, Management, Manufacturing, Product Development, Procurement, Leadership, Operations Management, Program Management, Quality Assurance, Software Documentation, Training
Education
Metropolitan State College of Denver 1998 — 2004
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Jennifer Abell Jennifer Abell's Reglera Experience February 2013 - August 2013
Job Project Coordinator at Integrity Electrical Solutions
Industry Construction
Experience
Integrity Electrical Solutions February 2014 - Present
Systems Contractors, Inc August 2013 - January 2014
Reglera February 2013 - August 2013
RK Mechanical September 2011 - February 2013
Examiner.com March 2011 - May 2011
Rivet Software January 2011 - April 2011
RK Mechanical April 2007 - April 2010
RK Mechanical April 2004 - April 2007
Skills
Training, Project Management, Customer Service, Software Documentation, Social Media, Customer Support, Microsoft Excel, Construction Management, Management, Contract Negotiation, Process Scheduler, Budgets, Construction, Contract Management, Negotiation, SharePoint, Sales, Project Planning, Troubleshooting, Quality Assurance, Inventory Management, Time Management, Purchasing, Supervisory Skills, MS Project, Human Resources, Proposal Writing, Project Estimation, Project Coordination, Procurement, Microsoft Office, Team Leadership, Process Improvement
Education
Metropolitan State University of Denver 2004 — 2011
Bachelor's Degree, Technical and Scientific Communication; Business Management
Integrity Electrical Solutions February 2014 - Present
Systems Contractors, Inc August 2013 - January 2014
Reglera February 2013 - August 2013
RK Mechanical September 2011 - February 2013
Examiner.com March 2011 - May 2011
Rivet Software January 2011 - April 2011
RK Mechanical April 2007 - April 2010
RK Mechanical April 2004 - April 2007
Skills
Training, Project Management, Customer Service, Software Documentation, Social Media, Customer Support, Microsoft Excel, Construction Management, Management, Contract Negotiation, Process Scheduler, Budgets, Construction, Contract Management, Negotiation, SharePoint, Sales, Project Planning, Troubleshooting, Quality Assurance, Inventory Management, Time Management, Purchasing, Supervisory Skills, MS Project, Human Resources, Proposal Writing, Project Estimation, Project Coordination, Procurement, Microsoft Office, Team Leadership, Process Improvement
Education
Metropolitan State University of Denver 2004 — 2011
Bachelor's Degree, Technical and Scientific Communication; Business Management
Kelly Nienburg Kelly Nienburg's Reglera Experience March 2013 - October 2014
Job Quality Assurance Project Manager at Dohmen Life Science Services, DLSS (formerly Reglera)
Industry Medical Devices
Experience
Dohmen Life Science Services, DLSS (formerly Reglera) January 2015 - Present
Dohmen Life Science Services, DLSS (formerly Reglera, LLC) October 2014 - January 2015
Reglera March 2013 - October 2014
Colorado State University June 2011 - March 2013
eOptra LLC April 2011 - November 2011
CSU Senior Design: Lab-on-a-Chip Diagnostic Biosensor August 2010 - May 2011
Housing and Dining Services, CSU August 2009 - May 2011
Residence Life, Housing and Dining Services, CSU August 2008 - May 2010
Alternative Spring Break November 2008 - March 2009
Skills
Matlab, Research, Statistics, Microsoft Office, Data Analysis, Higher Education, Mathematica, PowerPoint, Programming, Microsoft Excel, Public Speaking, Teaching, Microsoft Word, Critical Thinking, Laboratory
Education
Colorado State University 2008 — 2011
Bachelor of Science (BS), Chemical and Biological Engineering
Colorado State University 2008 — 2011
Bachelor of Science, Chemical and Biological Engineering
Dohmen Life Science Services, DLSS (formerly Reglera) January 2015 - Present
Dohmen Life Science Services, DLSS (formerly Reglera, LLC) October 2014 - January 2015
Reglera March 2013 - October 2014
Colorado State University June 2011 - March 2013
eOptra LLC April 2011 - November 2011
CSU Senior Design: Lab-on-a-Chip Diagnostic Biosensor August 2010 - May 2011
Housing and Dining Services, CSU August 2009 - May 2011
Residence Life, Housing and Dining Services, CSU August 2008 - May 2010
Alternative Spring Break November 2008 - March 2009
Skills
Matlab, Research, Statistics, Microsoft Office, Data Analysis, Higher Education, Mathematica, PowerPoint, Programming, Microsoft Excel, Public Speaking, Teaching, Microsoft Word, Critical Thinking, Laboratory
Education
Colorado State University 2008 — 2011
Bachelor of Science (BS), Chemical and Biological Engineering
Colorado State University 2008 — 2011
Bachelor of Science, Chemical and Biological Engineering
Sarah Sample-Reif Sarah Sample-Reif's Reglera Experience 2007 - 2007
Job National Vice President, Health IT at Modis
Industry Hospital & Health Care
Experience
Modis June 2013 - Present
CHIMSS July 2012 - July 2013
GDH Consulting December 2012 - May 2013
Innovative Consulting Group September 2012 - November 2012
Kforce Professional Staffing March 2008 - September 2012
Reglera 2007 - 2007
Cerner Corporation 1998 - 2007
Hessel Group 1997 - 1998
Skills
Healthcare Information..., Clinical Research, Epic Systems, Requirements Analysis, Cerner, Analytics, CTMS, Infrastructure, Healthcare, Technical Recruiting, Informatics, Enterprise Software, Internet Recruiting, Recruiting, Process Improvement, Strategy, Cold Calling, Telecommunications, Consulting, Hospitals, Sourcing, Talent Acquisition, Vendor Management, Business Development, Information Technology, Sales Operations, Project Management, Leadership, Business Intelligence, EHR, HIPAA, Networking, Applicant Tracking..., Contract Recruitment, EMR, Strategic Planning, Temporary Placement, Account Management, Revenue Cycle, Training, Professional Services, SDLC, Healthcare Industry, CRM, Staffing Services, Salesforce.com, Staff Augmentation, SaaS, Executive Management, Benefits Negotiation
Education
Palmer College of Chiropractic 1990 — 1991
CT, Technology
Cottey College 1988 — 1990
University of Colorado Denver
Business
Modis June 2013 - Present
CHIMSS July 2012 - July 2013
GDH Consulting December 2012 - May 2013
Innovative Consulting Group September 2012 - November 2012
Kforce Professional Staffing March 2008 - September 2012
Reglera 2007 - 2007
Cerner Corporation 1998 - 2007
Hessel Group 1997 - 1998
Skills
Healthcare Information..., Clinical Research, Epic Systems, Requirements Analysis, Cerner, Analytics, CTMS, Infrastructure, Healthcare, Technical Recruiting, Informatics, Enterprise Software, Internet Recruiting, Recruiting, Process Improvement, Strategy, Cold Calling, Telecommunications, Consulting, Hospitals, Sourcing, Talent Acquisition, Vendor Management, Business Development, Information Technology, Sales Operations, Project Management, Leadership, Business Intelligence, EHR, HIPAA, Networking, Applicant Tracking..., Contract Recruitment, EMR, Strategic Planning, Temporary Placement, Account Management, Revenue Cycle, Training, Professional Services, SDLC, Healthcare Industry, CRM, Staffing Services, Salesforce.com, Staff Augmentation, SaaS, Executive Management, Benefits Negotiation
Education
Palmer College of Chiropractic 1990 — 1991
CT, Technology
Cottey College 1988 — 1990
University of Colorado Denver
Business
John Nachtigall John Nachtigall's Reglera Experience June 2008 - September 2009
Job Sr. Manager of Design Assurance at Medtronic
Industry Medical Devices
Experience
Medtronic November 2011 - Present
Teleflex Medical September 2009 - August 2011
Reglera June 2008 - September 2009
AccessClosure, Inc. January 2007 - February 2008
Boston Scientific April 2003 - January 2007
Guidant Endovascular Solutions March 2001 - April 2003
Guidant Vascular March 2000 - March 2001
Guidant Vascular August 1997 - March 2000
Skills
Quality Assurance, Quality Systems, Process Validation, Design Control, Manufacturing..., CAPA, Remediation, CFR 820, ISO 13485, Risk Management, SOP Development, FMEA, Non-Conforming, Medical Devices, V&V, Quality System, Quality Auditing, Sop, Minitab, ISO 14971, R&D, Validation, Quality Control, FDA, Manufacturing, SOP development, Design of Experiments, Quality Management, Root Cause Analysis, DMAIC, Testing, 21 CFR Part 11, Product Development, Software Documentation, Process Improvement, Change Control, ISO, SPC, GMP, Supplier Quality, Cross-functional Team..., Process Simulation, Engineering, Lean Manufacturing, Six Sigma, 21 CFR, Continuous Improvement, Process Engineering, Injection Molding, Biomedical Engineering
Education
Colorado School of Mines 1994 — 1997
MS, Metallurgy and Materials Engineering
Colorado School of Mines 1990 — 1994
BS, Metallurgy and Materials Engineering
Medtronic November 2011 - Present
Teleflex Medical September 2009 - August 2011
Reglera June 2008 - September 2009
AccessClosure, Inc. January 2007 - February 2008
Boston Scientific April 2003 - January 2007
Guidant Endovascular Solutions March 2001 - April 2003
Guidant Vascular March 2000 - March 2001
Guidant Vascular August 1997 - March 2000
Skills
Quality Assurance, Quality Systems, Process Validation, Design Control, Manufacturing..., CAPA, Remediation, CFR 820, ISO 13485, Risk Management, SOP Development, FMEA, Non-Conforming, Medical Devices, V&V, Quality System, Quality Auditing, Sop, Minitab, ISO 14971, R&D, Validation, Quality Control, FDA, Manufacturing, SOP development, Design of Experiments, Quality Management, Root Cause Analysis, DMAIC, Testing, 21 CFR Part 11, Product Development, Software Documentation, Process Improvement, Change Control, ISO, SPC, GMP, Supplier Quality, Cross-functional Team..., Process Simulation, Engineering, Lean Manufacturing, Six Sigma, 21 CFR, Continuous Improvement, Process Engineering, Injection Molding, Biomedical Engineering
Education
Colorado School of Mines 1994 — 1997
MS, Metallurgy and Materials Engineering
Colorado School of Mines 1990 — 1994
BS, Metallurgy and Materials Engineering
Matthew Mapes Matthew Mapes's Reglera Experience December 2011 - July 2012
Job Operations Specialist at Evraz North America
Industry Mechanical or Industrial Engineering
Experience
EVRAZ North America August 2015 - Present
EVRAZ North America January 2014 - July 2015
HKA Enterprises September 2013 - December 2013
Colorado School of Mines May 2010 - May 2013
Reglera December 2011 - July 2012
Skills
Solidworks, Mechanical Engineering, Engineering, CAD, Microsoft Excel, AutoCAD, Manufacturing, MS Project, Project Management, Finite Element Analysis, Matlab, Product Development, Process Engineering, SolidWorks
Education
Colorado School of Mines 2013 — 2013
Master of Science (MS), Engineering Technology Management
Colorado School of Mines 2008 — 2013
Bachelor of Science (BS), Mechanical Engineering
EVRAZ North America August 2015 - Present
EVRAZ North America January 2014 - July 2015
HKA Enterprises September 2013 - December 2013
Colorado School of Mines May 2010 - May 2013
Reglera December 2011 - July 2012
Skills
Solidworks, Mechanical Engineering, Engineering, CAD, Microsoft Excel, AutoCAD, Manufacturing, MS Project, Project Management, Finite Element Analysis, Matlab, Product Development, Process Engineering, SolidWorks
Education
Colorado School of Mines 2013 — 2013
Master of Science (MS), Engineering Technology Management
Colorado School of Mines 2008 — 2013
Bachelor of Science (BS), Mechanical Engineering
Jennifer Mott Jennifer Mott's Reglera Experience August 2010 - December 2013
Job at
Industry Medical Devices
Experience
Dohmen Life Science Services July 2015 - Present
Dohmen Life Science Services, LLC (formerly Reglera, LLC) January 2014 - June 2015
Reglera August 2010 - December 2013
Skills
Data Entry, Spanish-speaking, Organizational..., Editing, Microsoft Word, Microsoft Excel, Access, CAPA, FDA, ISO 13485, Quality Assurance, Medical Devices, GMP, Process Improvement, Microsoft Office, Project Management, Quality System
Education
University of Colorado at Boulder 2005 — 2009
Bachelor of Arts (B.A.), Fine and Studio Arts
Dohmen Life Science Services July 2015 - Present
Dohmen Life Science Services, LLC (formerly Reglera, LLC) January 2014 - June 2015
Reglera August 2010 - December 2013
Skills
Data Entry, Spanish-speaking, Organizational..., Editing, Microsoft Word, Microsoft Excel, Access, CAPA, FDA, ISO 13485, Quality Assurance, Medical Devices, GMP, Process Improvement, Microsoft Office, Project Management, Quality System
Education
University of Colorado at Boulder 2005 — 2009
Bachelor of Arts (B.A.), Fine and Studio Arts
Linda Bisbee Linda Bisbee's Reglera Experience August 2006 - November 2007
Job Sole Owner at Painting with Threads
Industry Fine Art
Experience
EXN Engineering January 2009 - August 2009
Reglera August 2006 - November 2007
Lockheed Martin October 1996 - June 2006
Community College of Aurora August 1989 - August 1995
Skills
Statistics, Training, Six Sigma, Quality Assurance, Matlab, Technical Writing, Data Analysis, Continuous Improvement, Testing, Analysis, Process Improvement, Root Cause Analysis
Education
University of Colorado Denver 1986 — 1995
M.S., Applied Mathematics
Purdue University 1975 — 1977
M.S., Biology education
Birmingham-Southern College 1972 — 1975
B.S., Biology
EXN Engineering January 2009 - August 2009
Reglera August 2006 - November 2007
Lockheed Martin October 1996 - June 2006
Community College of Aurora August 1989 - August 1995
Skills
Statistics, Training, Six Sigma, Quality Assurance, Matlab, Technical Writing, Data Analysis, Continuous Improvement, Testing, Analysis, Process Improvement, Root Cause Analysis
Education
University of Colorado Denver 1986 — 1995
M.S., Applied Mathematics
Purdue University 1975 — 1977
M.S., Biology education
Birmingham-Southern College 1972 — 1975
B.S., Biology
Debra Stith Debra Stith's Reglera Experience March 2013 - April 2013
Job Quality Assurance and Regulatory Affairs Professional
Industry Medical Devices
Experience
Terumo BCT May 2014 - August 2014
Reglera March 2013 - April 2013
Hach Company April 2011 - June 2012
Carestream Health, Inc. October 2003 - December 2009
Eastman Kodak Company October 1997 - October 2003
Skills
Six Sigma, Lean Manufacturing, Quality Assurance, Process Improvement, Root Cause Analysis, Manufacturing, Validation, Continuous Improvement, Project Management, Black Belt, FDA, SAP, Regulatory Affairs, 21 CFR, Design Control, ISO 13485, ISO 14971, FDA GMP, Hazard Analysis, Risk Management, Six Sigma Black Belt, TQM, DMAIC, Failure Mode and..., New Product..., Problem Solving, Statistical Process..., Safety, Reliability Centered..., Chemical Engineering, Change Management, R&D
Education
University of Wisconsin-Madison 1977 — 1982
Bachelor of Science, Chemical Engineering
Colorado State University 2013 — 2013
Regulatory Affairs Certification in Medical Device, IVD, and Tissue Industry
Colorado State University 2013 — 2013
Regulatory Affairs Certification in Drug and Biologics
Terumo BCT May 2014 - August 2014
Reglera March 2013 - April 2013
Hach Company April 2011 - June 2012
Carestream Health, Inc. October 2003 - December 2009
Eastman Kodak Company October 1997 - October 2003
Skills
Six Sigma, Lean Manufacturing, Quality Assurance, Process Improvement, Root Cause Analysis, Manufacturing, Validation, Continuous Improvement, Project Management, Black Belt, FDA, SAP, Regulatory Affairs, 21 CFR, Design Control, ISO 13485, ISO 14971, FDA GMP, Hazard Analysis, Risk Management, Six Sigma Black Belt, TQM, DMAIC, Failure Mode and..., New Product..., Problem Solving, Statistical Process..., Safety, Reliability Centered..., Chemical Engineering, Change Management, R&D
Education
University of Wisconsin-Madison 1977 — 1982
Bachelor of Science, Chemical Engineering
Colorado State University 2013 — 2013
Regulatory Affairs Certification in Medical Device, IVD, and Tissue Industry
Colorado State University 2013 — 2013
Regulatory Affairs Certification in Drug and Biologics
Sarah Quraini Sarah Quraini's Reglera Experience November 2012 - July 2014
Job Regulatory Affairs Specialist II at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific September 2015 - Present
Dohmen Life Science Services July 2014 - August 2015
Reglera November 2012 - July 2014
Reglera July 2012 - October 2012
Colorado State University September 2009 - July 2012
IES Brain Research Foundation June 2010 - December 2010
Skills
Immunohistochemistry, CAPA, Clinical Trials, Biotechnology, Confocal Microscopy, Data Analysis, International..., Technical Files, 510(k) submission, ISO 13485, FDA, Lifesciences, Medical Devices, Validation, Regulatory Affairs, SOP, Quality System, Pharmaceutical Industry, Life Sciences, Quality Assurance
Education
Colorado State University 2006 — 2011
Master's, Biomedical Sciences--Neurobiology
Boston Scientific September 2015 - Present
Dohmen Life Science Services July 2014 - August 2015
Reglera November 2012 - July 2014
Reglera July 2012 - October 2012
Colorado State University September 2009 - July 2012
IES Brain Research Foundation June 2010 - December 2010
Skills
Immunohistochemistry, CAPA, Clinical Trials, Biotechnology, Confocal Microscopy, Data Analysis, International..., Technical Files, 510(k) submission, ISO 13485, FDA, Lifesciences, Medical Devices, Validation, Regulatory Affairs, SOP, Quality System, Pharmaceutical Industry, Life Sciences, Quality Assurance
Education
Colorado State University 2006 — 2011
Master's, Biomedical Sciences--Neurobiology
Ashley McPherson Ashley McPherson's Reglera Experience August 2012 - April 2014
Job Quality Engineer at Biomet
Industry Mechanical or Industrial Engineering
Experience
Biomet May 2014 - Present
Reglera August 2012 - April 2014
Gold Crown Volleyball September 2013 - November 2013
Cincinnati Sub-Zero January 2011 - August 2011
Cuyahoga Community College June 2008 - June 2010
Skills
Microsoft Word, Matlab, Training, Product Development, Teaching, AutoCAD, PowerPoint, Engineering, Technical Writing, Six Sigma, Continuous Improvement, Quality System, Lean Manufacturing, Process Improvement, Cross-functional Team..., Medical Devices
Education
University of Dayton 2008 — 2012
Bachelor, Mechanical Engineering
Strongsville High School
Biomet May 2014 - Present
Reglera August 2012 - April 2014
Gold Crown Volleyball September 2013 - November 2013
Cincinnati Sub-Zero January 2011 - August 2011
Cuyahoga Community College June 2008 - June 2010
Skills
Microsoft Word, Matlab, Training, Product Development, Teaching, AutoCAD, PowerPoint, Engineering, Technical Writing, Six Sigma, Continuous Improvement, Quality System, Lean Manufacturing, Process Improvement, Cross-functional Team..., Medical Devices
Education
University of Dayton 2008 — 2012
Bachelor, Mechanical Engineering
Strongsville High School
Gail Hamilton Gail Hamilton's Reglera Experience October 2012 - November 2012
Job Quality Systems Consultant
Industry Medical Devices
Experience
Acclarent 2015 - 2015
Redbock February 2014 - September 2014
Black Diamond Networks January 2013 - December 2013
Reglera October 2012 - November 2012
Validant April 2012 - September 2012
Validant December 2011 - April 2012
Terumo Cardiovascular Systems 2012 - 2012
Generic Medical Devices, Inc. August 2009 - October 2011
Abbott Diagnostics August 2000 - November 2008
Johnson & Johnson Medical, Inc. August 1991 - August 2000
Skills
CAPA, ISO 13485, FDA, Medical Devices, Quality System, Validation, Design Control, V&V, GMP, Biotechnology, Regulatory Affairs, GLP, 21 CFR Part 11, Change Control
Education
Stephen F. Austin State University 1977 — 1980
B.S.
Acclarent 2015 - 2015
Redbock February 2014 - September 2014
Black Diamond Networks January 2013 - December 2013
Reglera October 2012 - November 2012
Validant April 2012 - September 2012
Validant December 2011 - April 2012
Terumo Cardiovascular Systems 2012 - 2012
Generic Medical Devices, Inc. August 2009 - October 2011
Abbott Diagnostics August 2000 - November 2008
Johnson & Johnson Medical, Inc. August 1991 - August 2000
Skills
CAPA, ISO 13485, FDA, Medical Devices, Quality System, Validation, Design Control, V&V, GMP, Biotechnology, Regulatory Affairs, GLP, 21 CFR Part 11, Change Control
Education
Stephen F. Austin State University 1977 — 1980
B.S.
Ellen (Ellen Sandler) Kuebrich Ellen (Ellen Sandler) Kuebrich's Reglera Experience January 2006 - February 2008
Job VP of Sales and Marketing at Providigm
Industry Hospital & Health Care
Experience
Providigm February 2008 - Present
Reglera January 2006 - February 2008
Skills
Healthcare, Business Development, Strategic Planning, New Business Development, Account Management, Selling, Management, Salesforce.com, Team Building, Direct Sales, Training, Sales, Sales Operations, Budgets, Business Planning, Customer Service, Contract Negotiation, Product Management, Leadership, Project Management, Process Improvement, Marketing, Sales Process, Social Media Marketing, Business Strategy, CRM, Cold Calling, Customer Satisfaction, Start-ups, Lead Generation, Team Leadership, Forecasting, Strategic Partnerships, Strategy, Sales Management, Awesomeness, Sales Presentations
Education
University of Colorado at Boulder 1999 — 2001
Bachelor of Science, Advertising
Providigm February 2008 - Present
Reglera January 2006 - February 2008
Skills
Healthcare, Business Development, Strategic Planning, New Business Development, Account Management, Selling, Management, Salesforce.com, Team Building, Direct Sales, Training, Sales, Sales Operations, Budgets, Business Planning, Customer Service, Contract Negotiation, Product Management, Leadership, Project Management, Process Improvement, Marketing, Sales Process, Social Media Marketing, Business Strategy, CRM, Cold Calling, Customer Satisfaction, Start-ups, Lead Generation, Team Leadership, Forecasting, Strategic Partnerships, Strategy, Sales Management, Awesomeness, Sales Presentations
Education
University of Colorado at Boulder 1999 — 2001
Bachelor of Science, Advertising
Peggy Czyl's Reglera Experience June 2005 - April 2007
Job Project Manager at Pearson
Industry E-Learning
Experience
Pearson July 2008 - Present
Reglera June 2005 - April 2007
Active Education June 2003 - December 2004
Learn2 June 1999 - December 2002
Storage Technology Corporation / StorageTek June 1987 - May 1999
Skills
Certified Scrum Master, PMP Certified, Agile trained, Waterfall methodologies, People management, Vendor management, Problem solving /..., Calm under pressure, Excellent interpersonal..., Highly organized, Multitask and prioritize, MS Office, MS Project, PhotoShop, Localization Certified..., E-Learning, Program Management, Project Management, Agile Project Management, Software Project..., Agile Methodologies, Business Process, PMP, Quality Assurance, Leadership, Web Development, Product Development, Scrum, Software Documentation, Certified Scrum Master..., Visio, Project Portfolio..., PMO, Management, Interpersonal Leadership, Waterfall, Vendor Management, Photoshop, Microsoft Office, Calm
Education
University of Illinois at Urbana-Champaign 1978 — 1982
Bachelor's degree, Graphic Design
Pearson July 2008 - Present
Reglera June 2005 - April 2007
Active Education June 2003 - December 2004
Learn2 June 1999 - December 2002
Storage Technology Corporation / StorageTek June 1987 - May 1999
Skills
Certified Scrum Master, PMP Certified, Agile trained, Waterfall methodologies, People management, Vendor management, Problem solving /..., Calm under pressure, Excellent interpersonal..., Highly organized, Multitask and prioritize, MS Office, MS Project, PhotoShop, Localization Certified..., E-Learning, Program Management, Project Management, Agile Project Management, Software Project..., Agile Methodologies, Business Process, PMP, Quality Assurance, Leadership, Web Development, Product Development, Scrum, Software Documentation, Certified Scrum Master..., Visio, Project Portfolio..., PMO, Management, Interpersonal Leadership, Waterfall, Vendor Management, Photoshop, Microsoft Office, Calm
Education
University of Illinois at Urbana-Champaign 1978 — 1982
Bachelor's degree, Graphic Design
Jenn Theisen Jenn Theisen's Reglera Experience August 2006 - April 2008
Job President at Jennifer Theisen and Associates
Industry Hospital & Health Care
Experience
Jennifer Theisen and Associates May 2011 - Present
Centura Health April 2010 - Present
CO 3 - DMAT March 2010 - Present
TissueNet April 2008 - September 2012
All About Staffing January 2007 - June 2011
Reglera August 2006 - April 2008
Craig Hospital June 1998 - January 2007
Donor Alliance 2001 - 2004
Littleton Hospital 1999 - 2003
Skills
Tissue donor..., Quality and medical..., Administrative call, Hospitals, Medical Records, Healthcare, Tissue, Medical Devices, FDA, Leadership, Medicine, Training, Software Documentation, Critical Care, Management, Patient Safety, Nursing, Strategic Planning, Healthcare Management, Surgery, Clinical Research, Physicians
Education
Pickens Tech/Aurora Community College 2004 — 2006
Associates Degree, Respiratory Therapy
University of Northern Colorado 1992 — 1997
Bachelor, Kinesiology
Jennifer Theisen and Associates May 2011 - Present
Centura Health April 2010 - Present
CO 3 - DMAT March 2010 - Present
TissueNet April 2008 - September 2012
All About Staffing January 2007 - June 2011
Reglera August 2006 - April 2008
Craig Hospital June 1998 - January 2007
Donor Alliance 2001 - 2004
Littleton Hospital 1999 - 2003
Skills
Tissue donor..., Quality and medical..., Administrative call, Hospitals, Medical Records, Healthcare, Tissue, Medical Devices, FDA, Leadership, Medicine, Training, Software Documentation, Critical Care, Management, Patient Safety, Nursing, Strategic Planning, Healthcare Management, Surgery, Clinical Research, Physicians
Education
Pickens Tech/Aurora Community College 2004 — 2006
Associates Degree, Respiratory Therapy
University of Northern Colorado 1992 — 1997
Bachelor, Kinesiology
Stephen DeMars's Reglera Experience May 2012 - May 2013
Job Technical Service Specialist at Medtronic
Industry Medical Devices
Experience
Medtronic August 2015 - Present
Medtronic June 2013 - Present
Reglera May 2012 - May 2013
University of Colorado Mechanical Engineering Department August 2010 - January 2012
PharmaJet May 2011 - August 2011
Boulder City Parks and Recreation - Program May 2010 - May 2011
Saint John's Cathedral Camp June 2006 - June 2009
Skills
Medical Devices, Design Control, Engineering, Biomedical Engineering, Manufacturing, Matlab, Marketing, Labview, Microsoft Office, Sales, Solidworks, Microsoft Excel
Education
University of Colorado School of Medicine 2012 — 2013
Bachelor of Science (B.S.), Mechanical Engineering
University of Colorado at Boulder 2009 — 2013
Bachelor of Science (B.S.), Mechanical Engineering, Senior
Medtronic August 2015 - Present
Medtronic June 2013 - Present
Reglera May 2012 - May 2013
University of Colorado Mechanical Engineering Department August 2010 - January 2012
PharmaJet May 2011 - August 2011
Boulder City Parks and Recreation - Program May 2010 - May 2011
Saint John's Cathedral Camp June 2006 - June 2009
Skills
Medical Devices, Design Control, Engineering, Biomedical Engineering, Manufacturing, Matlab, Marketing, Labview, Microsoft Office, Sales, Solidworks, Microsoft Excel
Education
University of Colorado School of Medicine 2012 — 2013
Bachelor of Science (B.S.), Mechanical Engineering
University of Colorado at Boulder 2009 — 2013
Bachelor of Science (B.S.), Mechanical Engineering, Senior
Robert Feyerherm's Reglera Experience March 2009 - April 2010
Job Risk Management Consultant
Industry Medical Devices
Experience
Redbock October 2014 - April 2015
Oxford Global Resources December 2013 - January 2014
Avantec Vascular March 2011 - November 2013
Ops A La Carte LLC October 2010 - February 2011
Reglera March 2009 - April 2010
PolyRemedy November 2008 - February 2009
Novostent Corporation February 2006 - June 2008
Hospira October 2002 - February 2006
Skills
Quality System, Manufacturing, Design Control, ISO 13485, Medical Devices, CAPA, FDA, V&V, Validation, ISO 14971, R&D, Biomedical Engineering, FMEA, Design of Experiments, GMP, SPC, Quality Control, Minitab
Education
San Jose State University
BS, Industrial and Systems Engineering
Redbock October 2014 - April 2015
Oxford Global Resources December 2013 - January 2014
Avantec Vascular March 2011 - November 2013
Ops A La Carte LLC October 2010 - February 2011
Reglera March 2009 - April 2010
PolyRemedy November 2008 - February 2009
Novostent Corporation February 2006 - June 2008
Hospira October 2002 - February 2006
Skills
Quality System, Manufacturing, Design Control, ISO 13485, Medical Devices, CAPA, FDA, V&V, Validation, ISO 14971, R&D, Biomedical Engineering, FMEA, Design of Experiments, GMP, SPC, Quality Control, Minitab
Education
San Jose State University
BS, Industrial and Systems Engineering
Kim Bowers CQA, CBA, RAC's Reglera Experience July 2005 - February 2014
Job Site Quality Manager at Medtronic
Industry Medical Devices
Experience
Medtronic August 2014 - Present
KR Bowers Consulting March 2014 - Present
Reglera July 2005 - February 2014
Reglera (Israel) Ltd. July 2005 - February 2014
Boston Scientific 2007 - 2009
Boston Scientific Neuromodulation 2006 - 2008
DFC 2004 - 2005
DFC 2004 - 2005
Medtronic 1995 - 2004
Laser Alignment 1985 - 1991
Skills
Quality System, Quality Assurance, ISO 13485, CAPA, Design Control, FDA, V&V, Medical Devices, ISO 14971, Validation, 21 CFR Part 11, GMP, Quality Auditing, Change Control, ISO, Regulatory Affairs, Quality Control, Sop, Quality Management, Computer System...
Education
Grand Valley State University
Industrial Engineering, Engineering, Electronics
Millington Naval Air Station, Avionics
Avionics
Medtronic August 2014 - Present
KR Bowers Consulting March 2014 - Present
Reglera July 2005 - February 2014
Reglera (Israel) Ltd. July 2005 - February 2014
Boston Scientific 2007 - 2009
Boston Scientific Neuromodulation 2006 - 2008
DFC 2004 - 2005
DFC 2004 - 2005
Medtronic 1995 - 2004
Laser Alignment 1985 - 1991
Skills
Quality System, Quality Assurance, ISO 13485, CAPA, Design Control, FDA, V&V, Medical Devices, ISO 14971, Validation, 21 CFR Part 11, GMP, Quality Auditing, Change Control, ISO, Regulatory Affairs, Quality Control, Sop, Quality Management, Computer System...
Education
Grand Valley State University
Industrial Engineering, Engineering, Electronics
Millington Naval Air Station, Avionics
Avionics
Jill Norberg's Reglera Experience April 2012 - December 2012
Job Validation Professional
Industry Biotechnology
Experience
Quality Compliance Parners September 2015 - Present
MercuryGate International November 2014 - June 2015
GSK February 2014 - May 2014
Boehringer lngelheim April 2013 - December 2013
Reglera April 2012 - December 2012
Saint Jude Neuromedical October 2011 - April 2012
Dendreon March 2011 - September 2011
CIBA Vision December 2010 - March 2011
Abbott Nutrition July 2010 - December 2010
Online Business Applications August 2008 - April 2009
Skills
Medical Devices, Quality Assurance, Validation, Testing, Software Documentation, FDA, GMP, CAPA, 21 CFR Part 11, V&V, SDLC, Sop, Cross-functional Team..., Quality Control, Software Quality..., PI Data Historian, Delta V, Business Analysis, SAP BW, SAP Implementation, UML Tools, Rational Software..., Oracle ERP..., Adverse Event Reporting, Documentum, Reliance ETQ, QMS, Quality Management..., Enovia, CIP, SIP, Single-Use Bioreactors, Batch Processing, Aseptic Manufacturing, LIMS, Computer System..., Quality Auditing, GxP, Change Control, ISO, GAMP, Cleaning Validation, ISO 13485, User Acceptance Testing, System Testing, Regulatory Requirements, Requirements Gathering, Integration, Test Planning, GLP
Education
Seattle Central College 2014 — 2015
Certificate
Rochester Institute of Technology 1989 — 2000
Bachelor of Science Degree
State University of New York College at Brockport 1979 — 1981
Bachelor of Arts Degree
High School
Regents
Rochester Institute of Technology
Certificate
Rochester Institute of Technology
Bachelor of Science Degree
Quality Compliance Parners September 2015 - Present
MercuryGate International November 2014 - June 2015
GSK February 2014 - May 2014
Boehringer lngelheim April 2013 - December 2013
Reglera April 2012 - December 2012
Saint Jude Neuromedical October 2011 - April 2012
Dendreon March 2011 - September 2011
CIBA Vision December 2010 - March 2011
Abbott Nutrition July 2010 - December 2010
Online Business Applications August 2008 - April 2009
Skills
Medical Devices, Quality Assurance, Validation, Testing, Software Documentation, FDA, GMP, CAPA, 21 CFR Part 11, V&V, SDLC, Sop, Cross-functional Team..., Quality Control, Software Quality..., PI Data Historian, Delta V, Business Analysis, SAP BW, SAP Implementation, UML Tools, Rational Software..., Oracle ERP..., Adverse Event Reporting, Documentum, Reliance ETQ, QMS, Quality Management..., Enovia, CIP, SIP, Single-Use Bioreactors, Batch Processing, Aseptic Manufacturing, LIMS, Computer System..., Quality Auditing, GxP, Change Control, ISO, GAMP, Cleaning Validation, ISO 13485, User Acceptance Testing, System Testing, Regulatory Requirements, Requirements Gathering, Integration, Test Planning, GLP
Education
Seattle Central College 2014 — 2015
Certificate
Rochester Institute of Technology 1989 — 2000
Bachelor of Science Degree
State University of New York College at Brockport 1979 — 1981
Bachelor of Arts Degree
High School
Regents
Rochester Institute of Technology
Certificate
Rochester Institute of Technology
Bachelor of Science Degree
Miranda Kroehl's Reglera Experience June 2005 - October 2006
Job Biostatistician
Industry Biotechnology
Experience
University of Colorado Anschutz Medical Campus August 2013 - Present
University of Colorado Anschutz Medical Campus June 2011 - August 2013
University of Colorado Denver July 2010 - July 2011
University of Colorado Anschutz Medical Campus March 2008 - July 2010
University of Colorado Anschutz Medical Campus January 2010 - May 2010
University of Colorado Anschutz Medical Campus April 2007 - March 2008
Reglera June 2005 - October 2006
Biomedical Research Associates October 2004 - March 2005
Amgen 2004 - 2005
Skills
SAS, Data Analysis, Logistic Regression, Medical Devices, Mixed Model, Clinical Study Design, High Dimensional Data, Survival Analysis, Statistical Analysis, R, Mixed Models, Longitudinal Data, Missing Data, Sample size calculations, Manuscripts, Technical Writing, Power analysis, Study Design, Statistics, Clinical Trials, Immunology, SAS programming, Experimental Design
Education
University of Colorado at Denver 2009 — 2014
PhD, Biostatistics, 3.95
University of Colorado Health Sciences Center 2007 — 2009
M.S., Biostatistics, 3.97
Colorado State University 2000 — 2005
BS, Chemical Engineering, 3.4
University of Colorado Anschutz Medical Campus August 2013 - Present
University of Colorado Anschutz Medical Campus June 2011 - August 2013
University of Colorado Denver July 2010 - July 2011
University of Colorado Anschutz Medical Campus March 2008 - July 2010
University of Colorado Anschutz Medical Campus January 2010 - May 2010
University of Colorado Anschutz Medical Campus April 2007 - March 2008
Reglera June 2005 - October 2006
Biomedical Research Associates October 2004 - March 2005
Amgen 2004 - 2005
Skills
SAS, Data Analysis, Logistic Regression, Medical Devices, Mixed Model, Clinical Study Design, High Dimensional Data, Survival Analysis, Statistical Analysis, R, Mixed Models, Longitudinal Data, Missing Data, Sample size calculations, Manuscripts, Technical Writing, Power analysis, Study Design, Statistics, Clinical Trials, Immunology, SAS programming, Experimental Design
Education
University of Colorado at Denver 2009 — 2014
PhD, Biostatistics, 3.95
University of Colorado Health Sciences Center 2007 — 2009
M.S., Biostatistics, 3.97
Colorado State University 2000 — 2005
BS, Chemical Engineering, 3.4
Elena Guinto's Reglera Experience August 2009 - April 2010
Job QC Engineer III at Intuitive Surgical
Industry Medical Devices
Experience
Intuitive Surgical May 2013 - Present
C8 MediSensors March 2012 - January 2013
Sonitus Medical Inc. July 2011 - March 2012
Boston Scientific June 2010 - July 2011
Ken Block Consulting August 2009 - April 2010
Reglera August 2009 - April 2010
Boston Scientific, Fremont December 1994 - July 2009
Skills
Minitab, FDA, Six Sigma, Design Control, CAPA, ISO 13485, Design of Experiments, Lean Manufacturing, CE marking, Quality System, Manufacturing, V&V, DMAIC, Validation, Medical Devices, Manufacturing..., ISO 14971, FMEA, Biomedical Engineering, SPC, Root Cause Analysis, R&D, DFMEA, Supplier Quality, 21 CFR Part 11, PFMEA, GMP, Quality Auditing, Design Verification..., Quality Assurance, Change Control, Cross-functional Team..., Design for Manufacturing, Product Development, Quality Control
Education
California Polytechnic State University-San Luis Obispo 1986 — 1991
Bachelor of Science (BS), Industrial Engineering
Philippines
Intuitive Surgical May 2013 - Present
C8 MediSensors March 2012 - January 2013
Sonitus Medical Inc. July 2011 - March 2012
Boston Scientific June 2010 - July 2011
Ken Block Consulting August 2009 - April 2010
Reglera August 2009 - April 2010
Boston Scientific, Fremont December 1994 - July 2009
Skills
Minitab, FDA, Six Sigma, Design Control, CAPA, ISO 13485, Design of Experiments, Lean Manufacturing, CE marking, Quality System, Manufacturing, V&V, DMAIC, Validation, Medical Devices, Manufacturing..., ISO 14971, FMEA, Biomedical Engineering, SPC, Root Cause Analysis, R&D, DFMEA, Supplier Quality, 21 CFR Part 11, PFMEA, GMP, Quality Auditing, Design Verification..., Quality Assurance, Change Control, Cross-functional Team..., Design for Manufacturing, Product Development, Quality Control
Education
California Polytechnic State University-San Luis Obispo 1986 — 1991
Bachelor of Science (BS), Industrial Engineering
Philippines
Lisa Garcia Lawson's Reglera Experience 2011 - 2011
Job QA Manager at Indivior
Industry Biotechnology
Experience
Indivior (formerly Reckitt Benckiser Pharmaceuticals) May 2014 - Present
Hospira February 2013 - May 2014
Barry-Wehmiller Design Group 2012 - 2013
Reglera 2011 - 2011
Amgen 2009 - 2011
Amgen 2007 - 2009
Insmed 2006 - 2007
Eyetech 2005 - 2005
Sandoz 2003 - 2005
Amgen 1998 - 2003
Skills
GMP, Validation, FDA, CAPA, Quality System, Change Control, Quality Assurance, Biotechnology, HPLC, Quality Auditing, Manufacturing, Microbiology, ISO 13485, Technology Transfer, Quality Management, Medical Devices, Six Sigma, Aseptic Technique, Regulatory Affairs, Process Improvement, Environmental Monitoring, Technical Writing, Quality Systems, Process Validation, cGMP, SOP, Pharmaceuticals, Documentation, Compliance, Process Development, 21 CFR Part 11, LIMS, Cleaning Validation, Quality Control, Fermentation, Aseptic Processing, Purification, Sterilization, Biopharmaceuticals, GLP, Chromatography, V&V, Laboratory, R&D, Pharmaceutical Industry, Process Simulation
Education
Colorado State University
BS, MS, Microbiology
Indivior (formerly Reckitt Benckiser Pharmaceuticals) May 2014 - Present
Hospira February 2013 - May 2014
Barry-Wehmiller Design Group 2012 - 2013
Reglera 2011 - 2011
Amgen 2009 - 2011
Amgen 2007 - 2009
Insmed 2006 - 2007
Eyetech 2005 - 2005
Sandoz 2003 - 2005
Amgen 1998 - 2003
Skills
GMP, Validation, FDA, CAPA, Quality System, Change Control, Quality Assurance, Biotechnology, HPLC, Quality Auditing, Manufacturing, Microbiology, ISO 13485, Technology Transfer, Quality Management, Medical Devices, Six Sigma, Aseptic Technique, Regulatory Affairs, Process Improvement, Environmental Monitoring, Technical Writing, Quality Systems, Process Validation, cGMP, SOP, Pharmaceuticals, Documentation, Compliance, Process Development, 21 CFR Part 11, LIMS, Cleaning Validation, Quality Control, Fermentation, Aseptic Processing, Purification, Sterilization, Biopharmaceuticals, GLP, Chromatography, V&V, Laboratory, R&D, Pharmaceutical Industry, Process Simulation
Education
Colorado State University
BS, MS, Microbiology
Becky Sweeden's Reglera Experience March 2006 - Present
Job HR Director at Reglera LLC
Industry Medical Devices
Experience
Reglera March 2006 - Present
Enscicon Corporation March 2006 - Present
Geneva Pharmaceuticals September 1991 - April 2000
Education
Purdue University - Krannert School of Management 1984 — 1988
Reglera March 2006 - Present
Enscicon Corporation March 2006 - Present
Geneva Pharmaceuticals September 1991 - April 2000
Education
Purdue University - Krannert School of Management 1984 — 1988
Karema Chantasirivisal's Reglera Experience September 2007 - December 2009
Job Process Development Manager at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific January 2010 - Present
Boston Scientific January 2010 - Present
Boston Scientific October 2007 - December 2009
Reglera September 2007 - December 2009
Boston Scientific 2007 - 2008
superDimension 2007 - 2007
Reglera 2005 - 2007
Boston Scientific 2006 - 2006
Fischer Imaging 2005 - 2005
Education
California State University-Northridge 2011 — 2013
Master of Engineering (MEng), Engineernig Management
Colorado State University 2001 — 2005
Chemical Engineering
Boston Scientific January 2010 - Present
Boston Scientific January 2010 - Present
Boston Scientific October 2007 - December 2009
Reglera September 2007 - December 2009
Boston Scientific 2007 - 2008
superDimension 2007 - 2007
Reglera 2005 - 2007
Boston Scientific 2006 - 2006
Fischer Imaging 2005 - 2005
Education
California State University-Northridge 2011 — 2013
Master of Engineering (MEng), Engineernig Management
Colorado State University 2001 — 2005
Chemical Engineering
James Madden's Reglera Experience 2007 - 2007
Job Quality Manager in Medical Device Manufacturing Industry
Industry Medical Devices
Experience
Lake Region Medical December 2013 - Present
Accellent July 2013 - December 2013
Accellent February 2012 - July 2013
Accellent August 2010 - March 2012
Accellent August 2008 - August 2010
ConMED March 2008 - August 2008
Reglera 2007 - 2007
Boston Scientific 2007 - 2007
bioMerieux 2004 - 2007
Pharmaceutical Systems Inc 2002 - 2004
Skills
Validation, Medical Devices, ISO 13485, CAPA, SPC, Lean Manufacturing, Manufacturing, FMEA, Product Development, Quality Management, Process Validation, Root Cause Analysis, Quality Assurance, Risk Analysis, FDA, Quality Engineering, Quality Auditing, MS Project, Project Planning, International Project..., Engineering, ISO, Manufacturing..., Minitab, Supplier Quality, PPAP, QSR, Process Improvement, Problem Solving, Regulatory Affairs, Calibration, Statistics, cGMP, Process Engineering, Compliance, Inspection, Program Management, Strategic Planning, Quality System, Cross-functional Team..., Supplier Quality..., Gage R&R, Sop, V&V, GMP, Software Documentation, Quality Control, Design of Experiments, ISO 14971, Value Stream Mapping
Education
University of Illinois at Urbana-Champaign 1998 — 2002
Bachelor of Science, Mechanical Engineering
Lake Region Medical December 2013 - Present
Accellent July 2013 - December 2013
Accellent February 2012 - July 2013
Accellent August 2010 - March 2012
Accellent August 2008 - August 2010
ConMED March 2008 - August 2008
Reglera 2007 - 2007
Boston Scientific 2007 - 2007
bioMerieux 2004 - 2007
Pharmaceutical Systems Inc 2002 - 2004
Skills
Validation, Medical Devices, ISO 13485, CAPA, SPC, Lean Manufacturing, Manufacturing, FMEA, Product Development, Quality Management, Process Validation, Root Cause Analysis, Quality Assurance, Risk Analysis, FDA, Quality Engineering, Quality Auditing, MS Project, Project Planning, International Project..., Engineering, ISO, Manufacturing..., Minitab, Supplier Quality, PPAP, QSR, Process Improvement, Problem Solving, Regulatory Affairs, Calibration, Statistics, cGMP, Process Engineering, Compliance, Inspection, Program Management, Strategic Planning, Quality System, Cross-functional Team..., Supplier Quality..., Gage R&R, Sop, V&V, GMP, Software Documentation, Quality Control, Design of Experiments, ISO 14971, Value Stream Mapping
Education
University of Illinois at Urbana-Champaign 1998 — 2002
Bachelor of Science, Mechanical Engineering
Jean Vander Heyden's Reglera Experience September 2013 - December 2013
Job Post Market/MDR/Compliance Specialist
Industry Medical Devices
Experience
Fresenius Medical Care (ALKU) January 2015 - May 2015
Maetrics, LLC October 2013 - December 2014
Reglera September 2013 - December 2013
St. Jude NMD October 2012 - July 2013
Terumo Cardiovascular Systems September 2009 - August 2012
Skills
Medical Devices, CAPA, ISO 13485, Validation, ISO 14971, Change Control, Quality Auditing, Process Improvement, Minitab, Regulatory Affairs, Sop
Education
Metropolitan State University 1998 — 2006
Bachelor of Science (BS), Business Administration and Management, General
Inver Hills Community College 1983 — 1985
Associate of Science (AS), Health/Health Care Administration/Management
Fresenius Medical Care (ALKU) January 2015 - May 2015
Maetrics, LLC October 2013 - December 2014
Reglera September 2013 - December 2013
St. Jude NMD October 2012 - July 2013
Terumo Cardiovascular Systems September 2009 - August 2012
Skills
Medical Devices, CAPA, ISO 13485, Validation, ISO 14971, Change Control, Quality Auditing, Process Improvement, Minitab, Regulatory Affairs, Sop
Education
Metropolitan State University 1998 — 2006
Bachelor of Science (BS), Business Administration and Management, General
Inver Hills Community College 1983 — 1985
Associate of Science (AS), Health/Health Care Administration/Management
Rachele McCawley Robertson's Reglera Experience January 2008 - May 2010
Job High School Science Teacher at Aurora Public Schools
Industry Medical Devices
Experience
Aurora Public Schools July 2011 - Present
Adams 12 Five Star Schools June 2010 - May 2011
Reglera January 2008 - May 2010
Skills
Medical Devices, Sales Management
Education
University of Denver 2010 — 2011
Master of Arts (M.A.), Curriculum and Instruction
University of Colorado at Boulder 2004 — 2008
Bachelor of Arts (B.A.), Molecular, Cellular and Developmental Biology
Aurora Public Schools July 2011 - Present
Adams 12 Five Star Schools June 2010 - May 2011
Reglera January 2008 - May 2010
Skills
Medical Devices, Sales Management
Education
University of Denver 2010 — 2011
Master of Arts (M.A.), Curriculum and Instruction
University of Colorado at Boulder 2004 — 2008
Bachelor of Arts (B.A.), Molecular, Cellular and Developmental Biology
David Eliff's Reglera Experience August 2004 - May 2009
Job R&D Engineer at Covidien
Industry Medical Devices
Experience
Medtronic June 2011 - Present
Reglera August 2004 - May 2009
Edward Lifescience May 1997 - April 2003
Education
University of California, Irvine
BSME, mechanical design, propulsion, and power plants
Medtronic June 2011 - Present
Reglera August 2004 - May 2009
Edward Lifescience May 1997 - April 2003
Education
University of California, Irvine
BSME, mechanical design, propulsion, and power plants
Brad Riddell's Reglera Experience September 2004 - October 2005
Job Senior Security Consultant at Stanley Convergent Security Solutions, Inc.
Industry Security and Investigations
Experience
Stanley Convergent Security Solutions, Inc. August 2011 - Present
Integrity Electrical Solutions, LLC June 2011 - August 2011
MCS Fire and Security September 2010 - June 2011
SSD Systems August 2009 - September 2010
Echelon Partners July 2008 - August 2009
Sonitrol Corporation September 2005 - July 2008
Reglera September 2004 - October 2005
MMS Companies May 2002 - September 2004
Lanier Worldwide 1999 - 2003
Skills
Life Safety, Security, OnSSI, Bosch, Software House, AMAG, Axis, Lenel, DMP, CCTV, Fire Alarm, Analysis, Access Control, Alarm Systems, Surveillance, Account Management, New Business Development, Sales Management, Direct Sales, Video over IP, Biometrics
Education
University of Wyoming 1978 — 1981
BS, Accounting/Finance
Northwest College 1976 — 1978
AA, Psych
Stanley Convergent Security Solutions, Inc. August 2011 - Present
Integrity Electrical Solutions, LLC June 2011 - August 2011
MCS Fire and Security September 2010 - June 2011
SSD Systems August 2009 - September 2010
Echelon Partners July 2008 - August 2009
Sonitrol Corporation September 2005 - July 2008
Reglera September 2004 - October 2005
MMS Companies May 2002 - September 2004
Lanier Worldwide 1999 - 2003
Skills
Life Safety, Security, OnSSI, Bosch, Software House, AMAG, Axis, Lenel, DMP, CCTV, Fire Alarm, Analysis, Access Control, Alarm Systems, Surveillance, Account Management, New Business Development, Sales Management, Direct Sales, Video over IP, Biometrics
Education
University of Wyoming 1978 — 1981
BS, Accounting/Finance
Northwest College 1976 — 1978
AA, Psych
Catherine H's Reglera Experience 2011 - 2013
Job Quality Specialist currently looking for a Quality Position.
Industry Pharmaceuticals
Experience
Currently looking of a Quality Position. May 2014 - Present
The DiLisi Group Inc. June 2013 - February 2014
Reglera 2011 - 2013
Commissioning Agents, Inc 2004 - 2008
Skills
GMP, Sop, Quality Assurance, Biotechnology, Validation, Quality System, FDA, V&V, GLP, CAPA, HPLC, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Computer System..., SOP
Education
University of North Carolina at Greensboro 1986 — 1989
BS, Nutrition
Marymount College 1985 — 1986
Nutrition Sciences
Currently looking of a Quality Position. May 2014 - Present
The DiLisi Group Inc. June 2013 - February 2014
Reglera 2011 - 2013
Commissioning Agents, Inc 2004 - 2008
Skills
GMP, Sop, Quality Assurance, Biotechnology, Validation, Quality System, FDA, V&V, GLP, CAPA, HPLC, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Computer System..., SOP
Education
University of North Carolina at Greensboro 1986 — 1989
BS, Nutrition
Marymount College 1985 — 1986
Nutrition Sciences
Steve Yost, CQA's Reglera Experience November 2007 - November 2010
Job Principal Consultant, Owner at S3 Consulting, LLC
Industry Medical Devices
Experience
S3 Consulting, LLC October 2012 - Present
Becker and Associates Consulting November 2012 - Present
Spectranetics June 2012 - October 2012
Spectranetics February 2011 - June 2012
Reglera November 2007 - November 2010
FDA August 2002 - November 2007
Skills
FDA, Medical Devices, Life Sciences, Quality Systems, CAPA, US and European..., Class III medical..., Internal Audit, Post Market Surveillance, Regulatory Affairs, Compliance, 21 CFR Part 11, Quality System, ISO 13485, Validation, Class III, V&V, Quality Assurance, Sop, Clinical Research, GMP, Lifesciences, Clinical Trials, Regulatory Submissions
Education
University of Colorado Boulder 1994 — 1998
BS, Biology
S3 Consulting, LLC October 2012 - Present
Becker and Associates Consulting November 2012 - Present
Spectranetics June 2012 - October 2012
Spectranetics February 2011 - June 2012
Reglera November 2007 - November 2010
FDA August 2002 - November 2007
Skills
FDA, Medical Devices, Life Sciences, Quality Systems, CAPA, US and European..., Class III medical..., Internal Audit, Post Market Surveillance, Regulatory Affairs, Compliance, 21 CFR Part 11, Quality System, ISO 13485, Validation, Class III, V&V, Quality Assurance, Sop, Clinical Research, GMP, Lifesciences, Clinical Trials, Regulatory Submissions
Education
University of Colorado Boulder 1994 — 1998
BS, Biology
Shawn Tillery's Reglera Experience April 2007 - June 2010
Job QMS Document Control / Training Manager at McKesson Enterprise Information Solutions
Industry Pharmaceuticals
Experience
McKesson Provider Technologies December 2011 - Present
Norvartis / Sandoz September 2010 - December 2011
Reglera April 2007 - June 2010
Artesyn Technologies December 2000 - April 2007
E M Solutions August 1998 - December 2000
Accent Service Company January 1993 - August 1998
Skills
Quality System, Quality Assurance, Training, Software Documentation, CAPA, FDA, GMP, Human Resources, SharePoint, Recruiting, Quality Management, Management, Leadership, Change Control, ISO, Medical Devices, SAP, Payroll, Interviews, Manufacturing, Employee Benefits, Pharmaceutical Industry, Databases, Auditing
Education
University of Nebraska at Omaha 1994 — 1996
Human Resources / Management
Colorado School of Travel 1991 — 1992
Yes, Travel Industry
Bailey School of Broadcasting 1990 — 1991
Yes, Communications / Broadcasting
Northglenn 1985 — 1988
Diploma, Business
McKesson Provider Technologies December 2011 - Present
Norvartis / Sandoz September 2010 - December 2011
Reglera April 2007 - June 2010
Artesyn Technologies December 2000 - April 2007
E M Solutions August 1998 - December 2000
Accent Service Company January 1993 - August 1998
Skills
Quality System, Quality Assurance, Training, Software Documentation, CAPA, FDA, GMP, Human Resources, SharePoint, Recruiting, Quality Management, Management, Leadership, Change Control, ISO, Medical Devices, SAP, Payroll, Interviews, Manufacturing, Employee Benefits, Pharmaceutical Industry, Databases, Auditing
Education
University of Nebraska at Omaha 1994 — 1996
Human Resources / Management
Colorado School of Travel 1991 — 1992
Yes, Travel Industry
Bailey School of Broadcasting 1990 — 1991
Yes, Communications / Broadcasting
Northglenn 1985 — 1988
Diploma, Business
Kyle Witwer's Reglera Experience February 2013 - October 2013
Job Buyer at ZAP Engineering & Construction Services, Inc.
Industry Oil & Energy
Experience
ZAP Engineering & Construction Services, Inc. April 2014 - Present
ZAP Engineering & Construction Services October 2013 - Present
Reglera February 2013 - October 2013
Reglera August 2011 - December 2012
Reglera January 2011 - August 2011
Joseppi’s Italian Kitchen March 2008 - May 2010
Sheffield Steel January 2001 - January 2005
Skills
Quality Control, Outlook, Quality System, Quality Assurance, ISO 13485, Project Management, V&V, Sales Management, Microsoft Office, Process Improvement, Microsoft Excel, Visio, FDA, Procurement
Education
Oklahoma State University
B.S, International Business
ZAP Engineering & Construction Services, Inc. April 2014 - Present
ZAP Engineering & Construction Services October 2013 - Present
Reglera February 2013 - October 2013
Reglera August 2011 - December 2012
Reglera January 2011 - August 2011
Joseppi’s Italian Kitchen March 2008 - May 2010
Sheffield Steel January 2001 - January 2005
Skills
Quality Control, Outlook, Quality System, Quality Assurance, ISO 13485, Project Management, V&V, Sales Management, Microsoft Office, Process Improvement, Microsoft Excel, Visio, FDA, Procurement
Education
Oklahoma State University
B.S, International Business
Kelly Services
McKinsey & Company
The Boston Consulting Group
Bain & Company
BearingPoint
ICF International
Huron Consulting Group
A.T. Kearney