Sustaining PMO; supporting EP Rebranding efforts

CAPA Quality Assurance• Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills)• Develop, implement, and monitor various quality metrics using Power BI• Compile and present CAPA data for monthly and quarterly Quality Data Review Meetings for the Irvine, Minnetonka, Plymouth, and Rogers’ sites• Coordinate and drive efforts to assure CAPAs are opened and completed in accordance with Standard Operating Procedures and Work Instructions• Lead and create presentations and meeting minutes for CAPA Review Board Meetings with CAPA approvers and stakeholders for the Plymouth and Minnetonka sites• Ensure and execute process changes are implemented per change control procedures as a trained change control manager• Assisted in AQR training program as a WebEx Producer for seven CAPA Owner Certification courses• Drove efforts to create a new process with creation of new procedures and training program• Supported three BSI audits, one Internal audit, and one AQR audit at the Tech Center, Minnetonka, and Plymouth sites as a scribe and document reviewer• Executed four CAPAs through Investigation, Resolution Planning, Implementation, and Effectiveness Monitoring

Analyst for Vascular Access and Electrophysiology Medical Devices• Initiated, assess, analyze, and close customer complaints in EPIQ for vascular and electrophysiology devices• Utilized Standard Operating Procedures and Work Instructions from Windchill for complaint handling, CAPA procedures, and supporting internal and external audits• Assessed product manufacturing sites and return information in SAP• Processed complaint communications and assess files for regulatory compliance, reportability, and potential impact by communicating verbally and in writing both internally and externally• Performed on time medical device reporting to the FDA and EU competent authorities• Supported internal and external audits on the audit team by utilizing Business Objectives Software (BO) to provide complaint reports, and by reviewing complaint data, procedures, and work instructions• Communicated cross-functionally with other business units, and coworkers to carry out implementation tasks• Reviewed literature articles and clinical events for potential product complaints• Performed risk assessments by reviewing FMEAs

Emergency Room/ Urgent Care Representative-Complete Epic healthcare software training for scheduling, and updating patients information-Enforce all activities which involve placement and movement of patients using Epic Healthcare software-Register patient for various appointment types and schedule patients for Cardiology, Psychiatry, Orthopedic, and Family Medicine followup visits-Adjust and collect healthcare insurance for patients-Assign hospital beds for patients through communication with providers, nurses, and hospital supervisors-Monitor efficient transfers to and from surrounding facilities using Epic software

- Dissect a human cadaver for the purpose of students learning undergraduate anatomy - Collaborate with 6 other individuals on material and content necessary for dissecting the cadaver

Student teaching Assistant - Dissected cadavers for study purposes - Proctored 5 exams - Taught anatomy content including bones, muscles, brain, nerves, heart, vasculature, respiratory system, lymphatic system, digestive system, urinary system, male and female reproductive system

-Volunteered over 70 hours -Assisted visually impaired individuals with different tasks

-Communicated frequently with veterinarians and assistants regarding animal prognosis and care plans- Administered vaccines and obtained blood draws for further lab testing -Performed routine laboratory testing including urinalysis, blood panels, fecal analysis, and radiography

Avian Nest Monitoring - Evaluated 65 hours of Piping Plover and Least Tern nest behavior - Recorded and managed different nest behavior in Excel document spreadsheets - Presented research on aspects of population and behavioral ecology in endangered shorebird species

-Developed different educational games on topics including sexual health, alcohol, and other drugs