Demo

Quality Complaint Specialist

Online Technical Services, Inc.
San Diego, CA Full Time
POSTED ON 1/12/2025
AVAILABLE BEFORE 4/5/2025

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
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