Nikkole Sowers, MBA, PMP

Experience

• 

  Boston Scientific

  Aug 2004 - Jun 2011

  + Identified and communicated quality issues and concerns+ Coordinated and prioritized production and assigned appropriate resources+ Assembled Medical Devices as needed+ Trained resources on processes and maintained accurate training files+ Participated in project to implement barcodes on pouches and Instructions for Use + Performed in-process and finished good inspection activities on products+ Completed appropriate data forms to document the results of inspection activities+ Initiated nonconformance reports + Assembled Medical Devices through on-the-job training+ Followed all GMP Procedures+ Prepared necessary documentation+ Participated in multiple Kaizen Events

  • Product Builder IV

    May 2009 - Jun 2011

  • Quality Inspector

    Jan 2006 - May 2009

  • Product Builder I

    Aug 2004 - Jan 2006
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  Canberra Industries

  Nov 2012 - May 2013

  Quality Technician

  + Developed and managed quality procedures and processes+ Processed nonconformance's and verified failure had been resolved+ Managed, monitored, and controlled corrective and preventive action projects to ensure process improvement and team member participation+ Managed and monitored customer complaints+ Managed and monitored equipment calibration program+ Managed 5S methodology and continuous improvement+ Inspected products at various production stages per develop quality control plan+ Collaborated with suppliers regarding first articles, incoming components, and nonconformance resolution+ Conducted internal audits to verify compliance per ISO9001:2008+ Initiated, monitored, and implemented change requests throughout the project life cycle to satisfy stakeholder requirements + Managed project to create Bill of Materials in SAP to maximize work order efficiency Show less

• 

  Kimball Medical Solutions

  May 2013 - Mar 2022

  + Collaborated with Program Managers, Finance, Engineering, Quality, and Production to coordinate efforts for project completion+ Reviewed and edited start up documents, project presentations, and participated in project meetings+ Ensured projects stayed within the established scope+ Provided recommendations on areas for departmental or implementation process improvements+ Maintained, reviewed, and communicated project progress to internal and external stakeholders+ Monitored, tracked, and updated the campus project portfolio+ Developed and maintained project plans, project schedules, work hours, and budgets for multiple projects including new product introductions+ Organized and facilitated stakeholder meetings and distributed minutes. + Documented and followed up on important actions and decisions+ Coordinated day-to-day project team activities and communication+ Measured project performance using Microsoft Project and Excel+ Managed and monitored mold tool projects to ensure project on-time delivery and within scope+ Collaborated with stakeholders to assist in project activities Show less + Provided quality assurance/system expertise regarding product quality issues, new product development, and quality improvement opportunities to ensure regulations and standards are satisfied+ Participated in product implementation, from initiation to closing, by verifying complete, accurate, and proper performance of all functions+ Managed, monitored, and controlled corrective and preventive action projects to conduct root cause analysis and ensure process improvement+ Ensured processes meet internal and external requirements+ Initiated, monitored, and implemented change requests throughout the project life cycle to satisfy stakeholder requirements + Trained peers to quality principles and processes+ Managed, monitored and implemented Document Management System to store paper records electronically+ Participated in various quality improvement teams to provide guidance and assistance in development and implementation+ Managed Regulatory Inspection Audit Back Room to organize, prepare, and assist primary and secondary escorts with investigator requests. Show less

  • Project Coordinator

    Nov 2020 - Mar 2022

  • Document Control Coordinator

    May 2016 - Nov 2020

  • Quality Analyst

    May 2013 - May 2016
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  Boston Scientific

  Mar 2022 - now

  Specialist II, Project Management

  + Identified, coordinated, and led project teams with effective cross-functional communication and alignment to ensure timely completion of the project and/or tasks+ Generated and implemented project plans, built team ownership and commitment to the project plan+ Identified, managed, and communicated project risks+ Identified resources required for project activities and developed project budgets, resource allocations, and timelines+ Prioritized, delegated, and managed tasks among team members as appropriate to drive execution of project deliverables and minimize risk+ Documented project meeting minutes, issue log, decision log, metrics, and other key communications+ Prepared and delivered project status to management+ Managed individual project challenges and recommended solutions+ Ensured current BSC policies, practices, and documentation requirements are followed+ Collaborated with a variety of functions, regions, and business resources to achieve project objectives+ Interacted with senior personnel on complex matters requiring coordination between organizations Show less