Title: Quality Complaint Contractor
Duration: 6+ Months contract
Location: San Diego, CA
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 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
Education
- Minimum 1+ years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience
