Product Performance Analyst (Medical Device Complaint Investigation)

Main Responsibilities

• Initiates and manages the product experience file.
• Maintains accurate entry of product experiences in the database.
• Trips new product experience report files from time to time.
• Investigates events in a timely manner.
• Maintains accurate entry of product experiences in database.
• Records condition of returned products including observations and photographs.
• Interprets technical product specifications, Device History Records, or measurements obtained.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Independently assesses the product experience to determine if a medical device report needs to be filed with various global regulatory agencies.
• Independently assesses the complaint to determine if an escalation is required.
• Ensures accurate department procedures and work instructions are maintained.
• Supports inspections by regulatory agencies as requested.
• Provide support to Legal Department regarding product complaints.
• Works collaboratively with cross-functional groups.
• May coordinate product testing/analysis with other departments and external consultants.
• May track returned products within the database, as appropriate.
• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Requirements

• 4-year degree science background; bio, chem, life sciences, etc.
• Complaint handling, investigation of product performance experience nice to have
• Highly organized able to prioritize well
• Cross functional communication