Quality Assurance Auditor I - (South Jordan, UT)

SUMMARY OF DUTIES This position is responsible for auditing medical products to ensure that they have been manufactured according Merit's policies, procedures, specifications and standards. KEY FUNCTIONS PERFORMED Generation and distribution of NCMR's for specific area QAP's and MPS's. Audits the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations. Audits finished products to ensure that it conforms with Device History Records/applicable specification and procedures. Completes final inspection paperwork. Performs work order reviews for ECN's, EPWO's, NCMR's, etc. Documents inspections/rejections on inspection paperwork. Segregates product when discrepancies are noted. Initiates and ensures closure of NCMR's. Accountable for the disposition agreement/verification of NCMR's. Initiates, identifies (labels) and ensures closure of NCMR's. Enters info into NCMR database.