Medical Device Complaint & CAPA Lead

NeuWave Medical Inc.; Madison (WI); On-site; USD 65,000 - 85,000; Full time

Job summary

NeuWave Medical in Madison, WI is seeking a Complaint Handling Specialist to manage the intake, investigation coordination, and reporting of product complaints, ensuring timely regulatory compliance and thorough documentation.

You will lead cross-functional investigations, assign complaint numbers, and maintain the Complaint Log, while supporting CAPA activities, audit nonconformities, and CRB coordination.

Qualifications

• Bachelor's degree preferred; equivalent experience will be considered.
• 2+ years of medical device complaint handling experience.
• Proficient with Microsoft Office suite or equivalent.

Responsibilities

• Own the complaint lifecycle from intake through closure.
• Lead complaint investigations with cross-functional support and coordinate evaluations or repairs as needed.
• Perform MDR/vigilance determinations and file in the complaint record.
• Support CAPA initiation and documentation for complaint-related trends and investigation outcomes.
• Assist audit nonconformity investigations and corrective action documentation.
• Coordinate the Complaint Review Board (CRB) and report metrics to Management Review.

Skills

Medical device complaint handling

Microsoft Office proficiency

Education

Bachelor's degree preferred

Tools

ComplianceQuest eQMS

Job description

NeuWave Medical in Madison, WI is seeking a Complaint Handling Specialist to manage the intake, investigation coordination, and reporting of product complaints, ensuring timely regulatory compliance and thorough documentation.

You will lead cross-functional investigations, assign complaint numbers, and maintain the Complaint Log, while supporting CAPA activities, audit nonconformities, and CRB coordination.