Complaints Engineer I
Core
Investigate customer complaints for medical device products, perform root cause analysis, and ensure regulatory compliance.
Role type
Entry-level Quality Assurance Engineer (Complaints)
Builds
Investigation reports, trend analyses, and corrective action plans for medical device quality issues.
Domain
Medical Devices / Regulatory Quality Assurance
Deliverable
client delivery
Required skills
Root cause analysis, CAPA processes, regulatory standards knowledge (21 CFR 820, ISO 13485), data analysis in Excel, documentation authoring
Preferred skills
Cross-functional collaboration, trend analysis, sample evaluation
Technologies
Microsoft Excel, electronic complaint management systems
Responsibilities
Generate and analyze reports from the electronic complaint management system, conduct thorough investigations of assigned complaints including sample evaluations and interviews, document investigation findings in accordance with approved procedures, compile and present complaint summaries to support risk assessment, notify supervisors of adverse events, participate in cross-functional projects related to product quality
Seniority
Junior, closely supervised IC