Consumer Affairs Specialist - (Mansfield, MA)

Consumer Affairs Specialist one year with a possibility to extend Medtronic - Mansfield, MA Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury. CRITICAL FUNCTIONS: (1) Evaluates incoming complaint details and maintains the record in the electronic database. (2) Performs follow up activities to obtain additional info. (3) Use and maintain database(s), provide analysis and trending data all on complaints. (4) Determines Reportability of complaints to Government Agencies. (5) Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. (6) Ensures record documentation is maintained in a constant state of audit readiness per internal policies.