I have been fortunate to spend my entire career in the Medical Device industry since graduating from the University of Tennessee in May 1993. The focus of my work has been in Quality and Regulatory ranging from a Medical Device Consultant to a Director of RA/QA across many different products including sterilizable disposables, PET/CT scanners, dental polishers and scalers, blood analyzers, implantable neuromodulation devices, hospital OR lights, booms, routers and surgical tables. I moved to Texas about 10 years ago and have had the wonderful opportunity of being with Stryker Communications since March 2012. In that time, I've led the Post Market Quality team through a major transformation by attaining and growing tenured talent and establishing a customer focused-driven team of problem solvers! It is a thrill to come to work everyday and work with this talented team! Texas has been a great place for my husband and I to raise our 3 children - the mild winter months keep us hopping year round with outdoor kid's sports and activities! We do our best to ensure people understand that the "real UT" is the University of Tennessee! Go Vols!

Quality Engineering Manager, Post Marketing at Stryker Communications @ Joined the Stryker team in March 2012 and it has been a great experience! It is exciting to be part of such a foward-thinking and employee-focused company. I am currently responsible for a wonderful team of QEs whose responsibilities include post-marketing complaint management, risk analysis and escalation issues in the field. From March 2012 to Present (3 years 10 months) CAPA Manager, Quality Assurance @ Worked at St. Jude for 3 great years! Always rewarding to work under the Warning Letter environment and see the positive changes go into effect. Had the opportunity to create and implement a CAPA system and also build a CAPA QE department while continuing to support other Quality System efforts. Facilitated 3 FDA inspections and was part of the improvement efforts for managing FDA audits. From February 2009 to March 2012 (3 years 2 months)

Bachelor of Science (B.S.), Engineering Science and Mechanics @ University of Tennessee-Knoxville From 1989 to 1993 Jennifer Harris is skilled in: Quality Assurance, Design Control, Quality System, Cross-functional Team Leadership, ISO 13485, Management, Quality Control, FDA, CAPA, Medical Devices, Complaint Management, Testing, Validation, V&V, Six Sigma, FMEA