QA Complaint Analyst
Core
Manage customer complaints and post-market surveillance to ensure product quality, safety, and regulatory compliance in life sciences and diagnostics.
Role type
Quality Assurance Complaint Analyst
Builds
Quality records, investigation reports, CAPAs, and SCARs for product safety and compliance
Domain
Life sciences, diagnostics, biotechnology, in vitro diagnostics (IVD)
Deliverable
client delivery
Required skills
complaint investigation, root cause analysis, quality system process support, cross-functional collaboration, data documentation, workflow troubleshooting
Preferred skills
data analysis, instrumentation troubleshooting, SAP usage, ISO 13485 knowledge, 21 CFR Part 820/803 knowledge
Responsibilities
Receive and document complaints from customers and healthcare professionals; investigate product-related issues with cross-functional teams; support quality system investigations including nonconformances and CAPAs; communicate with internal teams and external customers to facilitate resolution.
Seniority
Entry-level to Mid-level, hands-on IC
