Complaint Evaluation Specialist

Complaint Evaluation Specialist (Medical Device) – Contract

Location: Acton

Pay Rate: Up to $34.00/hr.

We are hiring a detail-oriented Complaint Evaluation Specialist to support a leading medical device organization. This contract role focuses on complaint handling, data analysis, and regulatory compliance
, ensuring product quality and patient safety.

• Manage the full complaint lifecycle:
  intake, investigation, documentation, and closure
• Perform reportability assessments in line with FDA and ISO regulations
• Analyze complaint trends, generate reports, and support data-driven decisions
• Review Device History Records (DHRs) to identify product issues or anomalies
• Support adverse event investigations and basic failure analysis
• Maintain accurate records for complaints, audits, and special projects
• Assist with FDA, ISO, and internal audits
• Coordinate with cross-functional teams including Quality, Customer Care, and Engineering
• Train team members on complaint handling processes and systems

• Bachelor’s degree OR 3+ years of experience in medical device complaint handling or vigilance reporting
• 1–2+ years of experience in data management, documentation, or quality systems
• Strong understanding of regulatory standards (FDA, ISO, cGMP) preferred
• Excellent analytical, organizational, and problem-solving skills
• Strong technical writing and communication abilities
• Proficiency in Microsoft Office and database systems

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts