Vicky McElvain
Sr. Medical Technologist, R & D at Iris Diagnostics- Claim this Profile
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Bio
Experience
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Iris Diagnostics
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Medical Equipment Manufacturing
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1 - 100 Employee
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Sr. Medical Technologist, R & D
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Jan 2010 - Present
Sr. Medical Technologist, R & D
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Beckman Coulter Diagnostics
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Assurance Scientist
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Feb 1990 - May 2010
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QA Supervisor
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Jan 1990 - Nov 2009
Supervision of staff responsible for resolving customer complaints Supervised staff in all aspects of complaint investigation, including AE and recall presentations Heavily involved with CAPA investigations and reagent MRB process Consultant for some instrument/hardware MRB and/or manufacturing processes Active member of several Lean/Kaizen teams Core team member for development of Oracle based complaint/CAPA system Counsel subordinates due to extensive product knowledge… Show more Supervision of staff responsible for resolving customer complaints Supervised staff in all aspects of complaint investigation, including AE and recall presentations Heavily involved with CAPA investigations and reagent MRB process Consultant for some instrument/hardware MRB and/or manufacturing processes Active member of several Lean/Kaizen teams Core team member for development of Oracle based complaint/CAPA system Counsel subordinates due to extensive product knowledge base Wrote/updated departmental procedures on an annual basis Technical expert for many line support/current business projects
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Staff Specialist
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Jan 1996 - Jan 2004
Responsibilities: Serve as customer's voice within the corporation as well as supporting their position. Customer Advocacy position, required representing the customer's viewpoint at current business, quality assurance and program meetings Core team member for development of Lotus Notes complaint database Appointed ISO 9000 process representative in October Supported field service/sales on multiple chemistries via phone Team member for line support/current business… Show more Responsibilities: Serve as customer's voice within the corporation as well as supporting their position. Customer Advocacy position, required representing the customer's viewpoint at current business, quality assurance and program meetings Core team member for development of Lotus Notes complaint database Appointed ISO 9000 process representative in October Supported field service/sales on multiple chemistries via phone Team member for line support/current business projects Utilized as a resource by Technical Marketing and Hotline
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Senior Clinical Service Specialist
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Jan 1990 - Jan 1996
Responsibilities: Maintain/increase customer satisfaction by troubleshooting hardware/chemistry/software issues via the phone. Troubleshot all Beckman instruments over the phone, including hardware, chemistry, software and government regulations Core team member of RxPERT (chemistry based troubleshooting) project, developed entire chemistry troubleshooting section Considered leading expert for use and development of User Defined Reagent chemistries on the Synchron systems Developed… Show more Responsibilities: Maintain/increase customer satisfaction by troubleshooting hardware/chemistry/software issues via the phone. Troubleshot all Beckman instruments over the phone, including hardware, chemistry, software and government regulations Core team member of RxPERT (chemistry based troubleshooting) project, developed entire chemistry troubleshooting section Considered leading expert for use and development of User Defined Reagent chemistries on the Synchron systems Developed equitable 24-hour schedule for staff of 30 from a randomized volunteer process. Assisted with customer training classes when faced with a shortage of instructors Utilized as a resource by peers Co-wrote entire departmental procedure manual within 6 months of hire Used as fill in customer trainer when shortages occurred
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Development QA
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Jan 1990 - Jan 2009
Design Validation (2008 - 2009) Responsibilities: Clinical Study monitoring and data analysis Participated in new product development design validation process, especially clinical studies Wrote Clinical Study plans, protocols, reports Prepared presentations for Design Review
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Medical Technologist
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May 1979 - Feb 1990
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Chief Technologist
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May 1979 - Feb 1990
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Staff Technologist
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Oct 1976 - May 1979
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Providence
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Hospitals and Health Care
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700 & Above Employee
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Staff Technologist
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Jan 1976 - Oct 1976
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Staff Technologist
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Dec 1974 - Jan 1976
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Section Head Technologist
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Nov 1972 - Nov 1974
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Staff Technologist
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Sep 1970 - Sep 1972
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Education
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Southern Colorado State College
BS, Medical Technology -
Chadron State College
Pre-Med -
MT (ASCP), Medical Technology, St. Francis Hospital School of Medical Technology
B.S, Medical Technology; Pre-med Major