Complaint Specialist II
Core
Coordinate and supervise the implementation and monitoring of customer product complaints for medical devices, ensuring documentation compliance and resolution.
Role type
Mid-level quality complaint management specialist
Builds
Compliant complaint records and resolved quality issues for medical device customers
Domain
Medical device / Life sciences / Quality Assurance
Required skills
Quality system regulations knowledge, complaint investigation, data analysis, cross-functional collaboration, regulatory compliance, CAPA documentation, root cause analysis, ERP systems proficiency
Preferred skills
Trackwise, SA, BI Reporting tools, Excel
Responsibilities
Review and process customer product complaints daily; ensure compliance with documentation requirements and Quality System regulations; maintain accurate complaint records; verify peer work for accuracy; escalate quality concerns to leadership; prepare and analyze data trends; collaborate with cross-functional teams to resolve issues; participate in root cause investigations; provide guidance to associates on Quality System Requirements.
Seniority
Mid-level, hands-on IC
