Jessica Reed Email & Phone Number

Louisville, Kentucky, United States

Louisville, Kentucky, United States

Served as Quality Assurance Specialist responsible for managing CAPA/SCAR program, Change Management program, and company-wide ISO 13485 compliance. Responsible for updating Quality Procedures and publishing to the company ISO System Index. Worked with QA/Regulatory Manager during audit preparation and execution to ensure compliance and success for each facility. Generated monthly KPI reports through measuring compliance metrics, accompanied with presentation of analyses company-wide. Investigated all medical device related customer complaints/cases and provides appropriate follow-up. Managed Complaint Log and Nonconforming Materials Log. Responsible for maintaining training records for all employees. Performed label reconciliation on all medical devices for Kentucky plant

Served as Quality Control Supervisor responsible for managing a team of 6 Quality Control Technicians ensuring daily calibration and documentation is accurate and updated. Created production run folders for 3 lines using FIFO guidelines and case-count goals based on facility inventory. Utilized ERP system (ROSS) to determine paste assignment for each pizza sauce run. Managed foreign material incidents, including leading the team on navigating resolutions to ensure safety and quality of all products. Used CAPA program to identify the root cause of non-conformances, determine immediate resolutions, andimplement preventive actions.