Quality Engineer III/ Consumer Affairs Specialist III - (Carlsbad, CA)

Position title:Quality Engineer III/ Consumer Affairs Specialist III Job ID :15902 Location:Carlsbad CA 92008 Duration:seven months Job overview Determines reportability (MDR/MDV) of complaints to FDA and other international regulatory agencies. Evaluates incoming requests from the FDA and European Competent Authorities. Reviews and interprets risk management documentation as appropriate. Reviews and interprets trends associated with complaint events. Reviews complaint records and identify appropriate internal department(s) to obtain relevant info and coordinate efforts to compile relevant data. Provides technical ability and ensures response questions are answered completely and in compliance with all government agency regulations. Responds to and tracks requests for additional info from government agencies. Ensures record documentation is maintained in a constant state of audit readiness per internal policies. Manages and organizes workflow to accommodate strict deadlines.