Complaint Handling Specialist – Medical Device Quality

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