Quality Complaint Contractor

Job Description

Duties and Responsibilities:

• 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 generates 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.

Requirements:

• College degree OR experience in complaint handling – both preferred
• 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.
• Knowledge and experience using Electronic Quality Management System (OMNIFY) is helpful but will be taught so not required.

Interview:

• The manager will first conduct a phone interview and if interested will then conduct an in-person interview.