Complaint Handling Specialist

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

Position Summary

The Complaint Handling Specialist manages complaint intake, investigation coordination, and reporting documentation for NeuWave Medical's marketed products, ensuring complaints are handled thoroughly and within regulatory timelines. This role also supports CAPA activities and audit nonconformity investigations arising from complaint trends and findings.

Brief Description

The Complaint Handling Specialist manages complaint intake, investigation coordination, and reporting documentation for NeuWave Medical's marketed products, ensuring complaints are handled thoroughly and within regulatory timelines. This role also supports CAPA activities and audit nonconformity investigations arising from complaint trends and findings.

Key Responsibilities

• Own the complaint lifecycle from intake through closure.
• Determine whether each report meets the definition of a complaint; assign complaint numbers and maintain the Complaint Log.
• Lead complaint investigations with cross-functional support as required; verify product evaluations are completed and coordinate supplier evaluations or device repairs as needed.
• Perform MDR/vigilance reportability determinations by completing the applicable jurisdictional decision tree (FDA, EU MDR, Health Canada) and filing it with the complaint record.
• Support maintenance of the FDA ESG account and submission of eMDRs (FDA Form 3500A) and supplements within applicable regulatory timeframes.
• Document risk assessment and CAPA/SCAR assessment for every complaint; communicate with complainants where appropriate and document correspondence.
• Support CAPA initiation and documentation for complaint-related trends and investigation outcomes, including root cause and corrective/preventive action recordkeeping.
• Support audit nonconformity investigations and corrective action documentation arising from internal or external audit findings.
• Support coordination of the Complaint Review Board (CRB) and report complaint metrics to Management Review.

Required Qualifications

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

Preferred Qualifications

• Experience with eQMS platforms, specifically ComplianceQuest, is a plus.
• Familiarity with MDR/vigilance reporting requirements.
• Familiarity with CAPA and internal/external audit nonconformity processes.
• Familiarity with medical/clinical terminology relevant to interventional oncology.

Travel Requirements

Less than 10%.

Work Environment & Physical Demands

Work is primarily performed in an office and light-manufacturing/lab environment at NeuWave Medical's Madison, WI facility. Requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs. Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.

Equal Employment Opportunity

NeuWave Medical (a Precision IO Group company) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other status protected by applicable law.