What are the responsibilities and job description for the Complaint Handling Specialist – Medical Device Quality position at Tech Observer?
Summary:
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.
Skills:
Knowledge of QSR’s 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
Minimum 1-3 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience
BS/BA degree in scientific discipline desired
Salary : $25 - $30