Complaint Handling Specialist

Our Client is seeking a Complaint Handling Specialist to join their Quality team in Madison, WI. This individual will be responsible for managing the complaint lifecycle for marketed medical device products, including complaint intake, investigation coordination, regulatory reporting documentation, and closure.

This role will have a strong focus on complaint investigations, MDR/vigilance reporting, CAPA support, audit nonconformities, and regulatory compliance
. The ideal candidate will have hands‑on medical device complaint handling experience and be comfortable partnering with cross‑functional teams to ensure complaints are thoroughly investigated and completed within required regulatory timelines.

• Own the complaint lifecycle from initial intake through closure
  .
• Determine whether reported events meet the definition of a complaint, assign complaint numbers, and maintain the Complaint Log.
• Lead complaint investigations with cross-functional support and ensure appropriate product evaluations are completed.
• Coordinate supplier evaluations or device repairs when necessary as part of complaint investigations.
• Perform MDR/vigilance reportability determinations using applicable jurisdictional decision trees, including FDA, EU MDR, and Health Canada requirements.
• Support maintenance of the FDA ESG account and submission of eMDRs, FDA Form 3500A, and supplemental reports within applicable regulatory timelines.
• Document risk assessments and CAPA/SCAR assessments for complaints.
• Communicate with complainants when appropriate and maintain complete documentation of correspondence.
• Support CAPA initiation and documentation related to complaint trends and investigation outcomes.
• Assist with root cause analysis and corrective/preventive action documentation.
• Support investigations and corrective action documentation related to internal and external audit nonconformities
  .
• Assist with coordination of the Complaint Review Board (CRB) and preparation of complaint metrics for Management Review.

• Bachelor's degree preferred; equivalent professional experience will be considered.
• 2+ years of medical device complaint handling experience.
• Experience managing or supporting complaint investigations within a regulated medical device environment.
• Strong documentation, organization, and attention to detail.
• Ability to manage multiple investigations and regulatory timelines simultaneously.
• Proficiency with Microsoft Office or similar business applications.

• Experience working with electronic Quality Management Systems (
  eQMS
  ).
• Experience with Compliance Quest is a plus.
• Familiarity with MDR and vigilance reporting requirements
  .
• Familiarity with CAPA processes and internal/external audit nonconformity investigations.
• Familiarity with medical and clinical terminology related to interventional oncology
  .

This is an onsite position in Madison, Wisconsin
, working within an office and light manufacturing/laboratory environment. The position may require extended periods of sitting or standing, regular computer use, and occasional lifting of up to 25 lbs.