Product Complaints Analyst 2
Core
Process and investigate complaints for on-market medical devices, including record review, closure, and escalation of potential adverse events.
Role type
Quality Analyst (Medical Devices)
Builds
Compliance with quality regulations and accurate complaint handling records
Domain
Medical Devices / In-vitro Diagnostics (IVD)
Deliverable
dashboards & analysis
Required skills
Complaint handling, Adverse event identification, Quality regulations knowledge (21CFR820, ISO 13485, ISO 14971, IVDR), Electronic Quality Management System usage, Good Documentation Practice (GDP)
Preferred skills
Quality Certification (CQA, CQE), Engineering or Science degree, Advanced degree
Technologies
Electronic Quality Management System, Microsoft Office
Responsibilities
Review complaints for regulated products, Identify and triage potential adverse events, Monitor QA Complaint Handling inbox, Ensure adequacy and accuracy of complaint records, Support Global complaints for case handling audits
Seniority
Mid-level IC
