- Review initial complaint assessments for accuracy and completeness.
- Review initial complaint for preliminary reportability assessment and determination of potential hazard
- Work with departmental and interdepartmental personnel to ensure investigation activities yield the necessary information to determine the root cause of each complaint.
- Provide root cause analysis for each complaint investigated.
- Provide an assessment as to whether corrective or preventive action is required based on the outcome each complaint investigation.
- Ensure customer complaints are being processed in a timely manner.
- Ensure customer complaints are being processed in accordance with established company procedures and applicable regulatory standards.
- Performs other duties as requested.
- Bachelor’s Degree in related field required.
- 2+ years’ experience in medical device industry or other FDA regulated industry.
- Experience in failure analysis and scientific methodology will be required.
- Prior working experience with complaint analysis or root cause determinations would be preferred.
- Additional medical or statistical training/experience would be preferred.
- Ability to manage multiple issues, be organized, and manage timely workflow is required.
- Strong attention to detail and accuracy.
- Must possess the ability to effectively communicate in written and oral format.
- Must be a team-player, possess outstanding customer service skills and be self-motivated.
- Acts with a sense of urgency, illustrates ambition and drives for completion of tasks and projects.
- Must have the ability to initiative and develop creative solutions.
- Possess the ability to manage time and prioritize critical priorities.
- Must demonstrate the ability to increase knowledge.