Eddie Shimp Email & Phone Number

Bothell, Washington, United States

Bothell, Wa

Note: continued position from previous. EKOS Corporation was acquired by Boston Scientific in August 2019.● Configured, implemented, and administered new cloud-based QMS platform, MasterControl● Managed local CAPA system, including guidance and administration from initiation to closure of each record● Headed sterilization program, including cycle validation, qualification and review● Oversaw environmental and product monitoring program, including particulate, viable, aerosol, and dew point testing● Directed quality document control, training, finished goods release, and calibration teams● Led training of employees at multiple sites on QMS requirements, CAPAs, MasterControl, and various other subjects● Administered global electronic document management system and training system prior to transfer to MasterControl● Maintained and coordinated internal audit schedule, execution, and response● Prepared and presented QMS metrics, records, monitoring, and KPIs to local and global leadership● Performed gap analysis and updates to bring QMS in line with ISO 13485:2016 and EU MDR● Represented company during internal and external audits from various sources including FDA, BSI, and ANVISA● Managed 2 FTE in the areas of document control, training, and calibration

Bothell, Wa

Norman, Ok

● Selected, configured, implemented, and administered a new cloud-based QMS● Developed and implemented validation and risk management processes in manufacturing and design controls to ensure full compliance with ISO 13485 and ISO 14971 requirements● Planned and supervised validation of all production processes during a facility relocation● Trained personnel on risk management and led risk assessment/management on all company products and processes ● Led conversion of manufacturing documentation from a paper-based system to an electronic system● Located, audited, and tested new critical materials/suppliers as old suppliers became unavailable or insufficient● Implemented and managed new environmental monitoring system● Trained personnel or wrote technical documents on countless processes and instruments● Performed cross-department internal audits according to ISO 13485● Represented company during yearly BSI external audits

Norman, Ok

● Completed development and CE Mark certification of a novel IVD

University Of Oklahoma, Norman, Ok

Developed techniques for cell isolation, cell culture, cell adhesion assays, and biochemical assaysDesigned microfluidic flow equipment using AutoCAD and implemented it in laboratory settingActed as liaison and collaborated with departments across the country to achieve common goalsManaged multiple research projects simultaneouslyOversaw other graduate research projects in order to further the progress of the lab as a wholeSupervised and directed undergraduate students in developing their techniques and unique projectsPresented research results weekly to faculty and colleagues Contributed to published journal articles and poster presentationsOversaw lab purchasing and inventory for cell adhesion and protein patterning sectors

Mentored over 300 engineering students in sophomore- and junior-level classesPresented review sessions and answered questions for examsLectured during class time in professor absences and after class for recitationsOrganized career-, research-, and academic-related events with team of 11 other mentorsEvaluated student work on assignments and tests and provided feedback

Master Of Science (Ms), Bioengineering And Biomedical Engineering, 4.00 / 4.00

Bachelor Of Science (Bs), Chemical Engineering, 4.00 / 4.00

Activities and Societies: University Libraries Dean Search Committee, Student Advisory Council for University Libraries, American.