Quality Analyst - Complaints Management

Job Summary

Consistent application of Quality system standards to assigned Quality system area.

Responsibilities

• Develops solutions to routine assigned activities of moderate scope & complexity.
• Follows applicable Company / Unit procedures and may make updates to procedures and policies.
• Works within and across functions for assigned Quality systems.
• Accountable for setting own work direction and completing work tasks.
• Investigate customer complaints for assigned products and processes, including the identification of root causes and contributing factors wherever possible.
• Recommend corrective and/or preventative action(s) related to customer complaint issues.
• Identify and monitor patterns and trends in complaint issues related to assigned product groups.
• Provide a documented report that clearly outlines the investigation process, investigation findings, frequency of related events, corrective actions and recommendations.
• Develop test protocols and reports where required.
• Escalate high priority issues as well as identified business risks to the appropriate management level.
• Escalation of complaints and assist in complaint investigations as required.
• Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures.
• Development of Complaint Closure Letters as required.
• Work with Regional Complaint Centers to resolve and address complaint handling issues. Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports.
• Development and input to the MDR guidelines to identify failures leading to malfunction reporting requirements.
• Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements.
• Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance.
• Files MedWatch reports after Leader reviews and approves if applicable.
• Perform other duties as assigned.

Qualifications

• Consistent application of Quality system standards to assigned Quality system area.
• Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
• Requires a minimum of a Bachelors Degree
• Prefer Clinical, Science or Engineering
• Prefer a minimum 2-3 years relevant experience or a combination of equivalent education and relevant experience.
• Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft excel, word and PowerPoint.