Product Complaints Analyst 2
Core
Process and investigate complaints for on-market medical devices, including record review, closure, and triaging potential adverse events.
Role type
Quality Analyst (Medical Devices)
Builds
Regulated complaint records and quality reports
Domain
Medical Devices / In-vitro Diagnostics (IVD)
Deliverable
dashboards & analysis
Required skills
Complaint handling, Adverse event triage, Quality regulations (21CFR820, ISO 13485, ISO 14971, IVDR), Electronic Quality Management Systems, Microsoft Office
Preferred skills
Quality Certification (CQA, CQE), Medical device industry experience, Good Documentation Practice (GDP)
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