Job Title: Complaints Investigator

Location: Illinois (IL), USA

Experience: 5+ Years

Employment Type: Contract Job Summary

We are seeking a detail-oriented Complaints Investigator with 5+ years of experience in handling product complaints within a regulated environment. The candidate will be responsible for investigating complaints, identifying root causes, ensuring regulatory compliance, and supporting continuous quality improvement initiatives.

Key Responsibilities

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 5+ years of experience in complaint handling/investigation
• Experience in regulated industries (Medical Devices / Pharma / Biotech)
• Strong knowledge of FDA regulations, ISO standards, and GMP/GxP
• Hands-on experience in root cause analysis and CAPA processes
• Excellent documentation and communication skills

Preferred Qualifications

• Experience with complaint handling systems (TrackWise, Salesforce, etc.)
• Knowledge of MDR reporting / vigilance reporting
• Certification in Quality (ASQ, Six Sigma) is a plus

Key Skills

• Complaint Investigation
• Root Cause Analysis (RCA)
• CAPA Management
• Regulatory Compliance (FDA, ISO 13485)
• Documentation & Reporting