Title: Complaint Analyst
Reports to: Quality EngineerLocation: Onsite, 5 days a week
Employment type: Full-Time, Exempt
Pay range: $70,000 - $90,000

The Opportunity
Turn quality insights into action. We’re looking for a sharp, detail-oriented Complaint Analyst to own the complaint lifecycle, investigate returned products, and uncover trends that elevate our Quality Management System (QMS)

A Day in the Life

• Complaint Triage & QMS Logging: Review inbound feedback to determine if issues meet formal complaint criteria. Accurately enter details into Arena to prevent backlogs and ensure seamless tracking.
• Hands-On Device Investigation: Safely process and inspect returned devices, executing thorough physical analyses to identify primary failure modes and root causes.
• Data Analytics & Trend Tracking: Monitor return rates and complaint metrics to spot emerging patterns, evaluate product performance, and uncover process improvement opportunities.
• Management Reporting: Synthesize technical findings, trend reports, and metric summaries into clear reports for leadership review.
• QMS & Regulatory Compliance: Apply foundational Quality Management System principles, strictly adhering to internal SOPs and FDA regulations throughout every stage of the lifecycle.
• Continuous Improvement: Identify operational inefficiencies and offer constructive, actionable feedback to elevate team standards and overall quality.
• Timely Case Closure: Maintain rigorous documentation standards and attention to detail to execute precise, compliant, and timely file closures.

Skills and Experience

Required:

• Associate or bachelor’s degree in an engineering or technical discipline.
• Understanding of SQL, Python for querying databases, aggregating sparse records, and performing statistical analysis.
• Experience with QMS concepts and the role of quality assurance in the medical device manufacturing environment is highly desired.
• Strong written and verbal communication skills, analytical reasoning, attention to detail, and the ability to prioritize tasks to meet strict regulatory deadlines.

Physical Demands:

• Ability to lift, move, and handle package returns and testing objects weighing up to 20 pounds.