Complaints Handler

An employer is looking for a Complaints Specialist to join their team in Irvine, CA. The employer is a growing medical device company producing a diabetes management product for patients and the Complaints Specialist will join a Quality team. The Complaints Specialist will provide hands-on complaints handling and ensure customer complaints are reviewed and processed in a timely manner. Duties include, but are not limited to, day to day complaint review, investigation, adverse event reporting and complaints trending.

Responsibilities:

• Reviewing customer service calls (in Salesforce) and opening complaints where needed
• Processing open complaints through investigation and closure
• Coding complaints (as-reported and as-found) for trending purposes
• Determining if a complaint meets the MDR reporting requirements based upon the event
• Performs device history reviews for complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
• Evaluates all information from a regulatory and technical perspective to ensure appropriate analysis and investigation
• Interacts with the complaint investigation team regarding event information and investigation report status
• Participates in investigations and corrective action arising from customer complaints
• Ensures timely completion of complaint closures, including completion of investigations and communicates with supervisor and team members to ensure appropriate actions are taken
• Analyzes customer complaints trends and identifies potential corrective or preventive actions
• Maintains current and complete complaint files and ensures complaint files and records are in compliance with regulatory requirements

Requirements:

• Associate or higher degree in a scientific or engineering discipline, mechanical, electrical or software engineering preferred
• 2+ years practical experience in medical device complaint handling process
• Knowledge in FDA 21 CFR 820 and 21 CFR 803
• Experience working in a medical device industry
• Experience navigating electronic complaint system (Salesforce is a plus)
• Strong communication and organization skills required
• Accuracy, attention to detail, and thoroughness
• Proficiency required with Microsoft applications
• Experience submitting Medical Device Reports is a plus