Complaint Handling Specialist

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

• Location 3529 Anderson Street,Madison, WI, 53704,United States

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.

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.

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.