Surgitek Company
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Surgitek Employees
Hollister Incorporated 2010 - Present
Hollister Incorporated 2005 - 2010
Hollister Incorporated 2000 - 2005
Circon Corporation 1997 - 2000
Moxness Products / Mox-Med 1994 - 1997
Little Rapids Corporation 1991 - 1994
Surgitek 1979 - 1991
Skills
ISO 13485, Design Control, FDA, V&V, Cross-functional Team..., Quality System, Medical Devices, Validation, CAPA, Product Launch, Design of Experiments, Management, Global Marketing, GMP, 21 CFR Part 11, Six Sigma, R&D, Commercialization, Product Development, Leadership, Business Strategy, Engineering, ISO, Manufacturing, FMEA
Education
Clemson University
Bioengineers in Surgery
Milwaukee School of Engineering
MS, Engineering Management
University of Chicago Graduate School of Business
Strategic Marketing Management
University of Wisconsin-Parkside
BS, Applied Science - Mechanical Engineering
Snuggle Bug Cabin Rentals 2011 - Present
Carmen M. Morales, P.A. January 1995 - November 2013
Surgitek January 1993 - December 1994
Hill-Rom/Support Systems International, Inc. June 1987 - December 1992
Tallahassee Community Hospital 1985 - June 1987
Skills
Sales, Product Marketing, Sales Presentations, Business Development, New Business Development, Business Process..., Customer Service, Key Account Development, Customer Satisfaction, Customer Oriented, B2B, Office Administration, Legal Writing, Legal Research, Disaster Recovery, Entrepreneurship, Invoicing, Billing Systems, Microsoft Office, Microsoft Word, Microsoft Excel, Wordperfect, Timeslips, Time Matters, Healthcare, Medical Devices, Medical Terminology, Adobe Acrobat, PowerPoint, Presentation Folders, Business Planning, Nursing, Registered Nurses, Trade Shows, QuickBooks, Quality Management, Staff Development, Staff Management, Communication Skills, Corporate Communications, Marketing Communications, Organization, Contemporary Art, Visual Arts, Digital Photography, Photoshop, Creative Writing, Web Marketing, Rental Management, Vacation Rental
Education
Florida State University 1981 — 1984
Bachelor of Science (BS), Registered Nursing/Registered Nurse
Waterford Graded School District July 2009 - Present
Wateford Graded School Distric November 2002 - July 2009
ACMI January 1991 - December 2001
Surgitek November 1985 - December 1992
Skills
Certified School Risk..., Quality System, Iso 9000, ISO 13485, 21 CFR Part 11, CAPA, FDA, V&V, Medical Devices, CQA, Validation, Quality Auditing, Complaint Management, Quality Management, GMP, Quality Assurance, ASQ, Certified Medical..., Training, Manufacturing, Testing, Leadership, Workers Compensation, Customer Service, Staff Development, Teaching
Education
Marquette University 1981 — 1985
Bachelor of Science, Medical Technology
Agfa HealthCare April 2013 - Present
Siemens Medical Solutions USA, Inc. September 2010 - May 2013
Dilon Diagnostics, Inc August 2008 - September 2010
Fuji Film Medical Systems, USA, Inc April 2006 - August 2008
GE Healthcare/Fusion Sales September 2004 - April 2006
Medtronic January 2000 - January 2004
Zeneca Pharmaceuticals January 1998 - January 2000
STERIS Corporation January 1996 - January 1998
Surgitek January 1991 - January 1996
Xerox January 1987 - January 1991
Skills
Capital Equipment, Medical Imaging, Healthcare, Medical Devices, Marketing, Hospitals, Social Networking, Radiology, Urology, Sales Operations, Professionals, Surgeons, Sales, Surgery, Sales Management, Healthcare Information..., Selling, Direct Sales, Software Solution Sales, Budgets, Biomedical Engineering, Disposables, Cross-functional Team..., Executive Positions, Sales Presentations, Salesforce.com, Product Marketing, Physicians, Oil/Gas, Negotiation, Surgical Instruments, Forecasting, Selling Skills, radiation oncology, Informatics, Account Management, Hardware Diagnostics, Interventional..., Cardiology, HL7, Digital Imaging, Ultrasound, Oncology, Healthcare Industry, Digital X-ray, Stocks, Commodity Markets, Business Strategy, Mutual Funds, Marketing Strategy
Education
Texas A&M University 1982 — 1986
BS, Economics
Eagle Medical, Inc June 1997 - Present
Surgitek 1989 - 1991
Skills
Medical Devices, Gas Plasma..., Irradiation Validation, Packaging Validation, CAPA, ISO 13485, Validations, FDA, Quality Systems, Process Validation, GMP, cGMP, Quality Auditing, Quality Assurance, Supplier Quality, Change Control, V&V, 21 CFR Part 11, Quality System, Design Control, Root Cause Analysis, GxP, Validation, ISO 14971, Pharmaceutical Packaging, ISO
Education
Cal Poly San Luis Obispo
B.S, Environmental & Systematic Biology
ASRC Primus August 2000 - Present
USICE in Wisconsin August 2000 - Present
ACS GOVERNMENT SERVICES GROUP March 2000 - August 2000
INTERACTIVE BUSINESS SYSTEMS September 1998 - March 2000
Surgitek November 1996 - August 1998
Gander Mountain March 1996 - September 1996
toUS Army Reserve April 1986 - July 1996
US Army Reserve March 1986 - July 1996
SOUTHERN WISCONSIN CENTER November 1990 - March 1996
toUS Army, Worldwide November 1990 - March 1996
Skills
XP, Windows 7, Operating Systems, Technical Support, Hardware, Software Installation, Help Desk Support, System Deployment, Backup Exec, Printers, Windows, Blackberry, Workstations, Netbackup, Windows XP Pro, Windows 2000, Mobile Devices, Security Clearance, Outlook, Microsoft Office, Desktop Computers, Groupwise, Active Directory, Windows Server, Windows XP
Education
ITT Technical Institute-Greenfield 2015 — 2016
Bachelor of Science (BS), Information Systems and CyberSecurity
University of Phoenix 2002 — 2004
Master of Science, Computer Information Systems
University of Wisconsin-Oshkosh 1989 — 1990
Bachelor of Business Administration, Management Information Systems/Administrative Management
Mondi Group June 2014 - Present
Rust-Oleum December 2012 - May 2014
Intertractor America Corp December 2010 - December 2012
ACS Group March 2006 - January 2011
Liquid Container September 2005 - March 2007
RUUD LIGHTING 1995 - 2005
surgitek 1996 - 2004
Skills
Purchasing, Inventory Management, Kaizen, Lean Manufacturing, Logistics, MRP, Management, Manufacturing, Materials Management, Microsoft Excel, Microsoft Office, Microsoft Word, Negotiation, New Business Development, Operations Management, Process Improvement, Process Scheduler, Procurement, Product Development, Production Planning, Project Management, Project Planning, SAP, Sales, Sales Management, Six Sigma, Sourcing, Strategic Planning, Strategic Sourcing, Supply Chain, Supply Chain Management, Supply Management, Team Building, Time Management, Global Sourcing, Forecasting, Engineering, ERP, Customer Service, Cross-functional Team..., Contract Negotiation, 5S, Budgets, Continuous Improvement, Inventory Control
Education
j i case high school 1972 — 1975
Carthage College
Marquette University January 1999 - Present
Milestone Scientific January 1998 - January 1999
Surgitek September 1984 - September 1993
Baxter Healthcare September 1982 - September 1984
DePuy Orthopaedics August 1980 - September 1982
Skills
Engineering Design, Medical Device Product..., Biomedical Engineering, Forensic Engineering, Medical Devices, Patents, R&D, Materials, Cross-functional Team...
Education
Northwestern University 1993 — 1998
PhD, Biomedical Engineering
Northwestern University 1983 — 1986
Master of Engineering Management, Engineering Management
University of Michigan 1979 — 1980
MS, Bioengineering
University of Illinois at Urbana-Champaign 1975 — 1979
BS, General Engineering
Natus Medical 2014 - Present
Columbus Chemical Industries September 2012 - June 2014
Natus Medical, Inc./Nicolet Instruments March 2011 - August 2012
Merz Aesthetics April 2000 - January 2011
Surgitek January 1991 - April 2000
Skills
ISO 13485, Steam, Process Validation, Medical Devices, Quality Systems, Manufacturing, Quality Engineering, QSR, CAPA, Design Control, FDA, Quality Management, GMP, Auditing, 21 CFR Part 11, Supplier Quality, Document Management, Technical Writing, Chemical Processing, Process Control, Statistical Sampling, Quality System, V&V, Quality Control, Quality Assurance, ISO 9000, Medical Device..., Product Development, SPC, Continuous Improvement, Iso 9000
Education
University of Wisconsin-River Falls 1969 — 1973
BS, Earth Science, Biology
Milwaukee Area Technical College
Associates Degree, Water/Wastewater Technology
American Red Cross 2010 - 2014
American Red Cross 2001 - 2010
Baxter 1992 - 1999
Surgitek 1987 - 1992
Skills
Pharmaceutical Industry, Quality Assurance, FDA, Medical Devices, Biotechnology, Regulatory Affairs, Clinical Research, Process Improvement, 21 CFR Part 11, GLP, Validation, ISO 13485, Regulatory Requirements, Lifesciences, Sop
Education
Clemson University
BS, Biochemistry
Konecranes July 2012 - Present
ECHO Incorporated May 2010 - July 2012
Johnson Outdoors 2007 - 2008
Johnson Outdoors 2001 - 2007
Johnson Outdoors 2000 - 2001
Johnson Outdoors 1996 - 2000
Surgitek 1985 - 1995
Skills
Business Objects, Access Database, Software Documentation, Sarbanes-Oxley Act, Manufacturing, Pricing, Cross-functional Team..., Product Development, Project Management, Microsoft Office, PowerPoint, Microsoft Excel, Strategic Planning, Customer Service, JD Edwards
Education
Gateway Technical College 2000 — 2002
Logistics, Supervisory Management, Micro Computers, Mechanical Design, Logistics, Materials, and Supply Chain Management
Gateway Technical College 2000 — 2001
Supervisory Mangement, Human Resources Management/Personnel Administration, General
Nestle Health Science April 1997 - Present
Nestle HealthCare Nutrition 1997 - February 2001
Pfizer April 1990 - April 1997
Surgitek 1992 - 1997
Skills
Sales Management, Cross-functional Team..., Leadership Development, Mentoring, Strategic Planning, Hospital Sales, Surgical Oncology, Plastic Surgery, Medical Devices, Surgery, Product Launch, Pain Management, Leadership, Mergers & Acquisitions, Management, Key Account Development, Market Development, Marketing Strategy, Account Management, Selling, Pharmaceutical Sales, Business Development
Education
Miller Heiman Large Account Sales 2010 — 2011
Certification for completing the course, How to penetrate large accounts.
Rice University 1988 — 1989
Took Public Speaking
West Virginia University 1974 — 1979
BSN, Science and Nursing
Regulatory and Quality Solutions LLC (R&Q) 2015 - Present
Siemens Healthcare June 2007 - June 2015
Regulatory and Clinical Research Institute 2002 - 2007
Aastrom, BW Medical Group, and Veracel Biotechnologies 1998 - 2002
Dade Behring Ltd.(Baxter, Dade International) 1994 - 1997
Abbott 1990 - 1994
Surgitek 1981 - 1990
Skills
Informatics, Cross-functional Team..., Medical Imaging, Regulatory Affairs, Biomedical Engineering, Medical Devices, HL7, Healthcare Information..., Healthcare, FDA, Clinical Research, Process Improvement, Leadership, Pharmaceutical Industry, Radiology, Clinical Trials, HIPAA, Hardware Diagnostics, Strategy, Cardiology, Program Management
Education
Lake Forest Graduate School of Management
Master of Business Administration (M.B.A.)
Northeastern Illinois University
Master’s Degree, Chemistry
Cardiac Science April 2010 - Present
TomoTherapy May 2006 - January 2009
MRPC June 2005 - May 2006
Teel Plastics October 2001 - June 2005
SPX Process Equipment July 2000 - September 2001
ACMI August 1993 - July 2000
Surgitek 1991 - 1995
Skills
Design Control, Solidworks, Manufacturing, Medical Devices, Continuous Improvement, Lean Manufacturing, Product Development, CAD, Design for Manufacturing, Process Improvement, Six Sigma, Quality System, Cross-functional Team..., Mechanical Engineering, ISO 13485, Pro Engineer, FMEA, GD&T, Systems Engineering, Manufacturing...
Education
Marquette University 1991 — 1995
BS, Mechanical Engineering
Fresenius Kabi April 2013 - Present
Fresenius Kabi June 2012 - Present
Fresenius Kabi September 2010 - August 2012
Baxter Healthcare September 1995 - February 2010
Surgitek December 1993 - September 1995
Cordis June 1990 - December 1993
Boston Scientific January 1989 - May 1990
Skills
Planning, Requirements Analysis, Commercialization, Medical Devices, Cross-functional Team..., Budgeting, Resource Management, Budgets, CRM, CAPA, FDA, GMP, Leadership, Management, Manufacturing, PMP, Pharmaceutical Industry, Pharmaceutics, Product Development, Product Launch, Product Management, Project Management, Project Planning, Quality System, R, Risk Management, V, Validation, Business Strategy
Education
Project Management Institute 2003 — 2003
PMP
Boston University 1986 — 1991
B.S., Biomedical Engineering
Northampton High School 1983 — 1986
Sealed Air Corporation May 2011 - Present
DREW BROS TRUCKING, Franksville WI 1995 - 2012
Diversey Inc December 2004 - May 2011
JohnsonDiversey October 2001 - November 2004
Johnson Wax Professional April 1999 - September 2001
Olsten Staffing Services 1998 - 1999
Johnson Outdoors 1996 - 1998
SURGITEK 1994 - 1996
Skills
Accounts Payable, Internal Audit, Spreadsheets, Sarbanes-Oxley, Management, Employee Benefits, JD Edwards, Software Documentation, Analysis, Internal Controls, Lotus Notes, Accruals, Account Reconciliation, SAP, Microsoft Word, Access, Manufacturing, Financial Reporting, Auditing, General Ledger, Microsoft Excel, Customer Service, Sarbanes-Oxley Act, Teamwork, Accounting, Financial Analysis, Invoicing, Finance
Education
Gateway Technical College 1991 — 1993
Associates, Administrative Assistant/Information Processing
UroMatrix Medical Systems October 2011 - Present
MEDA November 2010 - March 2011
Vivus Inc March 2000 - November 2010
Surgitek 1984 - 1995
Skills
Urology, Pharmaceutical Industry, Medical Devices
Education
Florida State University 1967 — 1971
BS, Criminology & Corrections
Admiral Farragut Academy 1963 — 1967
High School
Merz Aesthetics Inc. July 2000 - Present
Surgitek 1983 - July 2000
Skills
Design Control, ISO 14971, Bioburden, Medical Devices, GMP, CAPA, Quality Control, Validation, Quality Auditing, FDA, Document Management, Sop, Quality System, Change Control, ISO 13485, USP, GLP, Quality Management, Stability Testing, Regulatory Affairs, Regulatory Requirements, 21 CFR Part 11
Education
Gateway Technical College
QC Technician
Fort Wayne Custom Rx April 2014 - April 2015
EdgeGuard 2012 - 2014
HealthTronics Laboratory Solutions 2009 - 2011
Galil Medical 2007 - 2009
US LABS 2004 - 2007
Apria Healthcare 2001 - 2004
Oncotech 1994 - 1999
Surgitek 1992 - 1992
Medtronic 1988 - 1992
Skills
Urology, Medical Devices, Capital Equipment, Oncology, Sales Force Development, Market Development, Surgeons, Operating Room, Business Development, Disposables, Hospitals, Sales Management, Surgical Instruments, Cardiology, Surgery, Product Launch, Healthcare, Orthopedic, Creative Planning, Strategic Planning, New Business Development, Account Management, Product Development, Biologics, Competitive Marketing..., Territory Management, Sales Presentations, Training, Budgeting, Projections, Complex Contract..., Regulatory Compliance
Education
DePauw University 1984 — 1988
BA, Psychology/Nursing