Experience

CoreMap

• United States
• Medical Device
• 1 - 100 Employee

• Head Of Quality Assurance

  • Apr 2022 - Present

• Head Of Quality Assurance

  • Apr 2022 - Present



BD

• United States
• Architecture and Planning

• Quality Assurance Engineering Manager

  • Jan 2020 - Apr 2022

• Staff Quality Engineer II

  • May 2018 - Jan 2020

• Staff Quality Engineer I

  • May 2014 - Apr 2018



Corindus Vascular Robotics

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Quality Engineer

  • Mar 2013 - May 2014

  • Authored Quality Plans and Risk Management Plans for new product development• Co-authored an Integrated Business Plan for a new product development project• Leading FMEA and Risk Analysis documentation effort for new product development• Authored QMS procedures including Process Control, Inspection, NCMR, and Product Development/Design Change Control• Completed a statistical analysis capability study of component dimensions to justify removal of inspection requirements• Created work instructions for Risk Indicator Reviews and currently leading monthly meetings with a cross functional team• Responsible for all in process and incoming inspection NCMRs, investigation activity, corrective action, and NCMR closure• Involved with Corrective and Preventative Action (CAPA) ownership, activities, implementation, and verification of effectiveness • Directly managed one in process inspector – coordinated inspection activity, training and provided engineering support• Directly involved with BSI microbiological audit and responsible for completing corrective actions based on feedback



St. Jude Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Engineer I-II

  • Feb 2010 - Feb 2013

  • Promoted to QE II after two years as a QE I • Core Team Member for Site Transfer Validation Activity• Core Team Member for New Product Development, Validation, and Release• Authored MVP and MVR Documents for New Product Launch• Co-Authored FMEA Documents• Process Validation Team Member: Wrote, Reviewed, and Approved IQ, OQ, PQ, PPQ, T/IMV Protocols and Reports• Provided Quality Engineering support for successful completion of two FDA Inspections with no 483 Observations• Developed and Edited Quality System Documents, Procedures, Work Instructions, and Forms• Provided Engineering Support, Managed Training Activity, and Coordinated Inspection Tasks in Supervision of the QC Inspection group (nine Inspectors and one Quality Technician)• Received a Divisional Award of Excellence in February 2012 for continually exceeding expectations• Originally employed by Lightlab Imaging, acquired by St. Jude Medical in July of 2010• Improved/Developed Manufacturing Work Instructions and Inspection Procedures • Inspected, Tested, and Wrote Investigation Reports for Imaging Catheter Post Sterile Testing failures to determine Root Cause• NCMR Administrator: Responsible for all Disposable Catheter Nonconforming Material Reports and NCMR Closure• Completed monthly reports for Disposables NCMRs and QA Inspection Metrics included in Risk Indicator Reviews• Analyzed data and wrote reports to support QA Activity for NCMR Investigations, CAPAs, and Engineering Change Requests• Created and Corrected Quality Control Practices and Test and Inspection Methods using Capability Studies and Metrology Concepts



ENVIRONMENTAL HEALTH & SAFETY DEPARTMENT - UNIVERSITY OF WISCONSIN

• Safety Equipment Tester

  • Jun 2008 - Jun 2009

  • Inspect and test emergency shower and eyewash stations on campus• Record inventory for fire suppression systems and update the fire extinguisher databases using MS Access• Inspect campus buildings for fire code violations, create and send violation reports, and track corrective actions • Inspect and test emergency shower and eyewash stations on campus• Record inventory for fire suppression systems and update the fire extinguisher databases using MS Access• Inspect campus buildings for fire code violations, create and send violation reports, and track corrective actions



Field Resources, Inc.

• United States
• Market Research

• Land Surveyor and Crew Chief

  • Jun 2003 - Aug 2006

  • Promoted to Crew Chief in 2006 after three summers as a crew member• Responsible for 2 people and 80% of the company's field work • Prepared Certified Plot Plans, As-built Certifications, and Height Certifications• Surveyed residential projects providing layout for new construction and topographical information to contractors and builders • Promoted to Crew Chief in 2006 after three summers as a crew member• Responsible for 2 people and 80% of the company's field work • Prepared Certified Plot Plans, As-built Certifications, and Height Certifications• Surveyed residential projects providing layout for new construction and topographical information to contractors and builders