Jay Heininger

Jay Heininger has a diverse work experience in various industries. Jay started their career as a Manufacturing Engineer at Hobart - PreMark Food Equipment Group, where they administered time studies, coordinated process control, and performed cost estimating. Jay also designed and implemented fixture designs and validated product testing.

Jay then moved on to Delphi Automotive Systems, where they worked as a Quality Supervisor and Senior Quality Engineer. In this role, they reduced customer complaints by 85% through root cause analysis and value-added auditing. Jay also trained staff, evaluated performance, and took disciplinary action.

After this, Jay worked as a Senior Quality Engineer at IMDS, where they focused on FDA-regulated implants. Jay was responsible for validation of special and standard processes, establishing documentation for ISO 13485 and FDA compliance, and executing IQ, OQ, PQ for special processes.

Next, they worked at UTC Aerospace Systems as a Senior Supplier Development Engineer in the aircraft landing systems division. Here, they engaged in supplier development activities and worked on key metric improvements in systems and supplier trend analysis.

Jay then joined NuVasive as a Staff Validation Engineer, working in a FDA-regulated environment for spinal implants. Jay was responsible for validation design and execution, as well as historical 483 remediation.

Jay'smost recent role was at Johnson Medtech, where they worked as a Quality Manager and Senior Quality Engineer. Jay oversaw validation and new product launch in an FDA-regulated environment for conductive printed circuits, in-vitro, and biosensor monitors. Jay also conducted a facility transfer and setup in a new location, and reduced customer complaints through root cause analysis.

Jay Heininger has a Bachelor of Science degree in Manufacturing Engineering Technology from the University of Dayton. Jay also holds a Masters of Business Administration (MBA) degree from the same university. The specific start and end years for their education are not provided.