Responsible for managing and maintaining Quality Systems, including,Nonconformance Investigations, CAPA System, Discrepant Material Reporting,Consumer Complaints, Discrepant Material Reporting, Consumer Complaints,and SOP Administration. Responsible for administration of consumercomplaints, including responding to incoming reports and performinginvestigations through arranging or performing product testing, review of batchrecords, personnel interviews, and other investigation tasks needed to identifyfailure modes. Change Control Coordinator, responsible for intaking changerequests, leading Change Control Board meetings, arranging status updates, andassisting change control owners in navigating the system and addressing barriersin performing changes. Responsible for the intake of Discrepant Material Reportsand collaborating with Supply Chain leadership on steps to close the report,including root cause and CAPA initiation. CAPA System Administrator,responsible for leading team members in CAPA identification, initiation, statusupdates, verifying compliance with executed actions, evaluating effectiveness,and ensuring documentation of each step. Responsible for performinginvestigations using root cause analysis for nonconformances and collaborationwith relevant departments to identify appropriate CAPA items. Responsible forperforming process and product risk assessments and authoring manufacturingcontrol plans. Responsible for authoring, revising, and reviewing SOPs andForms. Responsible for completion of supplier quality questionnaires.Responsible for compiling and presenting monthly, quarterly, and annual reportsfor each quality system. Responsible for performing Internal Audits. Responsiblefor providing direct support for external audits. Responsible for serving asQuality Manager in the absence of the facilities Quality Manager.