Complaint Handling Specialist

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

The Complaint Handling Specialist manages complaint intake, investigation coordination, and reporting documentation for Neu Wave 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.

• 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 time frames.
• 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.

• 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).

• Experience with eQMS platforms, specifically Compliance Quest, 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.

Less than 10%.

Work is primarily performed in an office and light-manufacturing/lab environment at Neu Wave 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.

Neu Wave 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.