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Role Description

We are seeking a Complaint Analyst to support Post-Market Quality activities by investigating product complaints, evaluating potential adverse events, and supporting complaint closure within the Quality Management System. The role involves analyzing field complaints, supporting product investigations, and ensuring complaint handling activities comply with FDA and ISO medical device quality regulations.

Key Responsibilities:

• Complaint Investigation
  • Assess incoming product complaints and determine applicable failure modes.
  • Evaluate complaints to identify potential adverse events and escalate when required.
  • Perform detailed complaint investigations and document findings in the Quality Management System.
• Complaint Processing
  • Ensure complaints are reviewed, investigated, and closed within required timelines.
  • Maintain complete and compliant complaint documentation.
• Product Evaluation
  • Support testing and evaluation of returned products associated with customer complaints.
  • Identify potential product issues and support root cause analysis.
• Risk Evaluation
  • Apply risk-based decision making using tools such as:
    • FMEA
    • Fault Tree Analysis (FTA)
    • Risk evaluation methodologies.
• Post-Market Surveillance Support
  • Provide input to Post-Market Surveillance teams regarding complaint trends and product performance.
  • Support complaint trending and quality metrics.
• Quality System Support
  • Support investigations including:
    • CAPA
    • Non-Conformance Events (NCE)
    • OOT investigations
    • Similar quality events.
• Cross-Functional Collaboration
  • Work with Manufacturing, Quality Engineering, R&D, Regulatory Affairs, and Clinical teams to resolve product issues.

Qualifications

• 7+ years of experience preferred.
• Experience in complaint analysis and quality management systems.

Requirements

• Strong analytical skills and attention to detail.
• Knowledge of FDA and ISO medical device quality regulations.
• Ability to work in a remote environment.

Benefits

• 100% remote work.
• Long-term contract opportunities.