Complaint Evaluation Specialist

Job Summary

A company is looking for a Quality Assurance Specialist.

Key Responsibilities

• Track all stages of the Complaint Documentation process including reportability determination and data analysis
• Maintain accurate documentation and files related to special projects, complaints, and lot qualification
• Assist during FDA, ISO, or internal audits and train team members on complaint coordination processes

Required Qualifications

• Bachelor's degree or 3+ years of experience in medical device complaint evaluation or vigilance reporting
• 1-2 years of experience in data management and record keeping
• Experience in troubleshooting within the medical device or related field
• Knowledge of FDA and ISO regulations is preferred
• Proficiency in MS Office and database systems