Job Title: Quality Complaint Specialist
Duration: 6 months w/ possibility for an extension
Responsibilities:
Monitor the Complaint Handling inbox regularly for new complaints and adverse event reports.
Create and manage complaints in the eQMS (electronic Quality Management System), and input data into the Master Complaint Tracker.
Attach relevant files and reports related to complaints in the eQMS, such as PC/AE reports, follow-up communications, reportability assessments, log files, etc.
Organize and create complaint folders in SharePoint to facilitate investigation and collaboration activities.
Perform DHR (Device History Record) reviews for complaint investigations.
Update complaint investigation summaries with administrative details, including complaint number, PC/AE report information, device information, etc.
Generate log files and attach them to both the eQMS and SharePoint complaint folders.
Track handpiece returns inventory and submit weekly requests to the 3PL (third-party logistics) provider for return shipments.
Required Skills:
Knowledge of QSRs (Quality System Regulations) and their application.
Experience in complaint handling.
Ability to work proactively and collaborate with managers and operational teams to resolve quality issues.
Strong time management skills, with the ability to handle multiple tasks and maintain self-motivation.
Excellent written, verbal, and interpersonal communication skills in English.
Proficiency in Microsoft Word, Excel, and SharePoint.
Additional Information from Hiring Manager:
This role is 100% onsite.
The position is a temporary replacement for an employee on leave, but there may be opportunities for contract extension or potential conversion to a full-time role if performance is strong and budget allows (no guarantees).
Experience with Microsoft Word, Excel, and SharePoint is required.
The role involves post-market complaint handling.
The average number of complaints per day is approximately 5
Job Types: Full-time, Contract, Temporary
Pay: $30.00 - $33.00 per hour
Expected hours: No less than 40 per week
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: In person
