Jenna Pich (Kilgore) Email & Phone Number

Denver, Co, Us

Denver, Co, Us

Marlborough, Ma, Us

Developed data strategy for Sourced Finished Medical Device (SFMD) Supplier Quality organizationCreated Power BI reports for supplier quality, including integrations with Power Apps and Power Automate

Minneapolis, Mn, Us

Stood up and ran enterprise wide supplier CAPA boards as a CAPA SpecialistDeveloped supplier CAPA report in PowerBI to monitor metrics and timeliness of CAPA phasesCompleted a technical and compliance review of all records at all phasesCreated training content for CAPA process and Trackwise systemCoached supplier CAPA owners on SCAPA processSuperuser in electronic CAPA system (Trackwise)

Minneapolis, Mn, Us

Managed Contract Manufacturing and OEM suppliers including supplier changes, supplier CAPAs, supplier quality agreements, etcActed as CAPA Specialist on supplier CAPA board which included reviewing sCAPA records, hosting sCAPA Board meeting, creation of Best Practices Playbook for sCAPA, and development of sCAPA reporting toolsServed as a Business Representative on a major software upgrade project which impacted nearly 30 Medtronic sites

Minneapolis, Mn, Us

Split role - 50% Supplier Quality Engineering in Receiving Inspection, 50% Regulatory Affairs Specialist Lead implementation of Supplier Owned Quality program for the Boulder, CO siteReduce inspection times in Receiving Inspection departmentExecute process improvements for Quality Engineering functionsPerform and document regulatory assessments of changes to products in manufacturing based on FDA guidance documents including notification to international regulatory groups

Marlborough, Ma, Us

Team lead for Value Improvement ProjectsManaged indirect service suppliers (such as analytical and calibration labs) globally including on-site quality assessments based on ISO 13485 and 17025, supplier corrective actions (SCAR), and supplier change impact assessments (SCIA)Drove supplier consolidation efforts and moved business toward preferred suppliersTeam member on multiple acquisition teams in relation to supplier controlsTeam member on global non-conformances/CAPA relating to supplier controls

Wayne, Pa, Us

Performed troubleshooting on the catheter manufacturing floor to identify and solve problems on a daily basisWrote and executed IQ/PQ/OQImplemented process improvements resulting in reduced waste as well as clearer, more compliant documentation processes Investigated non-conformances and implemented Corrective/Preventive Actions to remove root causes of the problemsLed TFX Plymouth’s Continuous Improvement Project and implemented CIP ideas

New York, New York, Us

Investigated and improved procedure for accountability limit calculations resulting in more reliable data for quality decisions and reduced labor and product waste Mapped manufacturing processes and proposed improvements to quality council

Lab technician in an antisense oligonucleotide production labPerformed quality control with mass spectrometry and UV quantification, assisted in oligonucleotide synthesis, prepared columns for chemical synthesis, purified productsBegan designing a machine for larger scale production including 3D modeling on SolidWorks

Performed various jobs in food service industry including serving in a fine dining restaurant and running private partiesResponsible for training new employees, forming schedules and organizing duties of servers

Woodbury, Mn, Us

Assisted research and development group in various projects including wet and dry grinding technology, dispersions, and prilling Performed particle analysis including size, viscosity, and SEM imagingManufactured products on a larger scale for customersPresented research findings to colleagues and customers

Chanhassen, Mn, Us

Master'S Degree, Engineering Management

Bachelor Of Science (Bs), Biomedical/Medical Engineering

Education record