Medical Device Complaints Lead

Kids for the Future; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

NeuWave Medical in Madison, WI seeks a Complaint Handling Specialist to manage intake, investigations, and regulatory reporting for marketed medical devices. You will coordinate CAPA activities, ensure timely MDR/vigilance determinations, and maintain robust complaint records.

The role supports audit investigations and cross-functional teams across QA, regulatory, and operations. Required: 2+ years in medical device complaint handling, a Bachelor’s or equivalent, and proficiency with MS Office;

Qualifications

• Bachelor's degree preferred; equivalent experience considered.
• 2+ years of medical device complaint handling experience.
• Proficient with standard office software (Microsoft Office).

Responsibilities

• Own the complaint lifecycle from intake through closure.
• Determine whether each report is a complaint; assign numbers and maintain the log.
• Lead investigations with cross-functional support; coordinate repairs as needed.
• Perform MDR/vigilance determinations and file with records.
• Support FDA ESG accounts and eMDR submissions within regulatory timelines.
• Document risk assessments and CAPA/SCAR for each complaint.
• Support CAPA initiation and corrective/preventive action documentation.
• Assist audit nonconformity investigations and corrective actions.
• Coordinate Complaint Review Board and report metrics to management.

Skills

Medical device complaint handling

MS Office

Cross-functional coordination

Education

Bachelor's degree or equivalent experience

Tools

eQMS ComplianceQuest

Job description

NeuWave Medical in Madison, WI seeks a Complaint Handling Specialist to manage intake, investigations, and regulatory reporting for marketed medical devices. You will coordinate CAPA activities, ensure timely MDR/vigilance determinations, and maintain robust complaint records.

The role supports audit investigations and cross-functional teams across QA, regulatory, and operations. Required: 2+ years in medical device complaint handling, a Bachelor’s or equivalent, and proficiency with MS Office;