Global Complaint QA Specialist

Job Title: Global Complaint QA Specialist

Location: Remote

Hours/Schedule: M-F 8:30am-4:30pm ET

Type: Contract (6 months)

Overview

Our client in the CPG industry is seeking an individual to drive business compliance with global product vigilance requirements, coordinate follow-up between vigilance process partners, and provide insight on trends of complaints. If you’re interested in joining this dynamic team, apply today!

Responsibilities

• Coordinates complaint follow ups with vigilance and global contact center partners to ensure all available information is obtained from complainant.
• Performs weekly complaint / event data reconciliation activities to mitigate risk of reportable events not being reviewed in accordance with regulatory timelines.
• Responsible for the submission of medical device near-incident reports to the applicable health authority in accordance with regulatory timelines.
• Ensures documentation of reportability decisions are noted within the complaint file.
• Performs assigned data quality tasks to ensure data integrity of complaint and vigilance files.
• Reports key metrics from the global vigilance process to Vigilance and QA Team leadership to measure and control the performance of the vigilance process.
• Supports Vigilance team leadership as required with project or ad-hoc activities.
  
  

Requirements

• Bachelor’s degree from accredited institution (Science, Bio-medical preferred)
• 5 years experience with complaint handling processes preferred.
• Ability to complete daily/monthly tasks as assigned to ensure timely delivery of outputs.
• Able to follow requirements of SOP, WI, or documented decision trees.
• Able to deliver required regulatory outputs in a prioritized manner.
• Able to balance multiple priorities to ensure the requirements of the complaint handling system are met in a timely manner.
  
  

#M3

Ref: #101-All Depts