The Complaint Evaluation Specialist position is responsible for individual projects, training, and documentation support for team members. The role involves reviewing and monitoring data and document quality as requested by the manager. Administrative support includes data analysis, reporting, trending, documentation review, coordination of complaints and lot qualification data, device history reviews, and reviewing/closing certain complaint categories.

Responsibilities include:

Track all stages of complaint documentation process, including reportability determination, data analysis, reporting and trending, documentation review, coordination of complaint and lot qualification data, device history reviews, and review and closure of complaints
Maintain accurate documentation and files related to special projects, complaints, and lot qualification
Analyze lot documentation (DHRs) to identify anomalies
Support database development and reporting capabilities
Assist during FDA, ISO, or internal audits
Train team members on complaint coordination
Support review and investigation of adverse events
Conduct basic product review and failure analysis
Perform additional duties as required

Education & Experience:

Bachelor's degree OR 3+ years in medical device complaint evaluation or vigilance reporting
1-2 years experience in data management, record keeping, and troubleshooting in medical device or related field

Preferred Skills:

Knowledge of FDA and ISO regulations
Strong documentation and data analysis skills
Experience with complaint handling systems/databases
Strong communication and technical writing skills
Ability to prioritize and manage multiple tasks
Proficiency in MS Office and database systems