Complaint Analyst

Overview

Responsibilities

• Independently investigate and document moderate- to high-complexity product complaints.
• Coordinate product analysis, service evaluations, engineering assessments, and event coding.
• Maintain complete, accurate, and compliant complaint records.
• Assess regulatory reportability and support MDR, Vigilance, and other adverse event reports.
• Review post-market service information for complaint criteria and proper classification.
• Analyze complaint and performance data for quality, safety, reliability, and compliance trends.
• Escalate issues requiring CAPA, risk management review, regulatory assessment, or corrective action.
• Improve regulatory decision trees, complaint evaluation processes, and complaint handling procedures.
• Prepare written communications on events, investigations, findings, conclusions, and corrective actions.
• Report quality problems, product defects, and compliance concerns to management.

Qualifications

• A relevant bachelor's degree is preferred; equivalent education and experience will be considered.
• Requires complaint investigation, product performance evaluation, and regulatory documentation experience.
• Requires professional English reading, writing, and verbal communication.
• Requires a couple of working hours of overlap with a team operating 7:30 AM to 5:30 PM PDT.
• Adverse event evaluation and regulatory reportability experience is preferred.
• Requires practical knowledge of ISO 13485, FDA medical device regulations, and ISO 14971 principles.
• Requires knowledge of global medical device regulations and reporting requirements.
• eQMS and complaint management database experience is preferred.
• Requires analytical thinking, technical communication, independent work, and cross-functional collaboration.

Physical Requirements