Supplier Quality Engineer

Ability to effectively communicate, facilitate and organize project activities relating to ensuring supplier quality. Develops and manages project schedules to ensure deadlines are met. Serves as the primary Quality contact for suppliers and provides technical assistance to management for suppliers as requested. Works with supplier development engineering to performs on-site annual and critical component supplier audits to ensure compliance with Quality Systems procedures and CSI requirements. Generates audit reports and ensures supplier audit findings are tracked to timely and closure. Provides quality systems input to suppliers such as, but not limited to: statistical process control, gage R&R studies, and capability studies. Resolves supplier quality issues at incoming inspection and the production line. Provides project team leadership and conducts investigations relating to supplier quality issues. Completes non-conforming material reports (NCMR), supplier requests for change (SRC), supplier corrective action requests (SCARs) and monitors follow-up with assigned supplier base. Routinely reports on supplier performance per defined metrics to management and other team members. Represent Quality during audits and interface with FDA, ISO, or any external auditor.