Location: San Diego,CA, USA
MUST be strong with Excel, Word, Sharepoint Knowledge and experience using Electronic Quality Management System (OMNIFY) is helpful but will be taught so not required. Is this post-market complaint handling - YES Education - college degree OR experience in complaint handling - both preferred Ideally some experience working with medical device product - DEVICE Duties: Regularly monitors Complaint Handling inbox for new complaints and adverse event reports Generates complaints in the eQMS and adds data inputs to Master Complaint Tracker Attaches all relevant files and reports for the complaint to the eQMS e.g. PC/AE reports, Follow-Up communications, Reportability Assessments, log files etc. Organizes and generate Complaint folders in SharePoint to help with investigations and collaboration activities Performs DHR review for Complaint investigations Updates Complaint investigation summary with administrative information including complaint number, PC/AE report information, Device information etc. Creates- log files and attaches to the eQMS and SharePoint Complaint folder Monitors Handpiece returns inventory and places weekly requests with 3PL for return shipments Skills: Knowledge of QSRs and their application Complaint handling experience Ability to work proactively and cooperatively with managers and operational staff to solve quality problems Ability to manage multiple responsibilities with a high degree of self motivation Good written, oral, and interpersonal English communication skills Ability to use Microsoft Word and Excel applications Education: Minimum 1-3 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience