Senior Product Complaints Analyst
Core
Investigate product complaints and adverse events, lead quality improvement initiatives, and manage CAPA activities for medical devices and IVD products.
Role type
Senior Product Complaints Analyst
Builds
Quality improvement processes and compliant complaint management systems
Domain
Life Sciences / Medical Devices / In-vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
complaint investigation, CAPA management, root cause analysis, regulatory compliance knowledge, cross-functional project leadership, quality documentation, risk assessment
Preferred skills
Quality Certification (CQA, CQE), experience in life sciences or IVD industry, knowledge of 21CFR820, ISO 13485, ISO 14971, IVDR
Technologies
Microsoft Office Products
Responsibilities
Identify, assess, and track potential adverse events and field actions; lead product and process improvements to reduce complaints; facilitate evaluation of complaints including investigation and containment; write and review quality documents such as investigation reports and SCAR responses; support audits and inspections; provide training on quality initiatives.
Seniority
Senior, hands-on IC
