Quality Complaint Analyst
Core
Manage the full lifecycle of product complaints, from intake through investigation and closure, ensuring accurate documentation and regulatory compliance.
Role type
Quality Complaint Analyst
Builds
Complaint handling processes and regulatory reporting
Domain
Medical devices / Dialysis
Required skills
FDA Quality System knowledge, ISO 13485, ISO 14971, Risk Management, GMP, Reportability determination, Cross-functional collaboration, Regulatory awareness
Preferred skills
1+ years in regulated industry, Engineering or technical degree, MS Office/Visio proficiency
Technologies
MS Office, Visio, Adobe Acrobat
Responsibilities
Execute and maintain complaint handling process, Facilitate complaint lifecycle progress, Perform reportability determinations, Provide information for Adverse Event reporting, Collaborate with Customer Support/Engineering/Service teams, Support additional Quality Systems activities
Seniority
Entry-level to Junior