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Global Complaint Resolution Manager

Global Complaint Resolution Manager

SentecLincoln, RI, US
1 day ago
Job type
  • Full-time
Job description

Global Complaint Resolution Manager

The Global Complaint Resolution Manager is responsible for leading the complaint handling process and post-market activities for active medical devices, with a focus on high-risk and high-complexity cases. This role provides functional leadership to a team of complaint specialists, ensuring regulatory compliance, process optimization, and continuous improvement. The position includes training and mentoring the team, managing Field Safety Corrective Actions (FSCA) and recalls, and supporting trend analysis. This position is based in Lincoln, RI and will work closely with, and as an extension of, the Sentec AG and Percussionaire Inc. Quality Assurance teams.

Essential Duties and Responsibilities :

Complaint Handling & Team Leadership

  • Serve as process owner for the global complaint handling system
  • Functionally lead and mentor a team of complaint specialists
  • Oversee complaint intake, documentation, and classification
  • Escalate potentially reportable events to Regulatory Affairs

Post-Market Surveillance

  • Manage operational tasks for FSCA and product recalls
  • Focus on resolution of high-risk and high-complexity complaints
  • Support QA in monitoring and identifying complaint trends
  • Cross-Functional Collaboration

  • Work closely with Service, QA, Regulatory Affairs, and Clinical Application Specialists to assess failure modes and track high-risk complaints and associated actions
  • Conduct error and problem analysis in collaboration with development teams
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    Complaint Resolution • Lincoln, RI, US

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