Associate II, Complaints
Core
Process, investigate, and monitor product defect complaints to ensure regulatory compliance and enhance quality control systems.
Role type
Associate II, Complaints (Professional Path)
Builds
Unified product defect investigation operating procedures and compliant complaint processing systems
Domain
Medical devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, structured problem solving, regulatory reporting, SOP adherence, cross-functional collaboration, technical expertise in complaint processing
Preferred skills
familiarity with medical device or pharmaceutical regulations
Technologies
GxP regulations, Standard Operating Procedures (SOPs)
Responsibilities
Process and investigate product defect complaints; monitor trending and reporting of defects; address and expedite complaints under company policy; support activity monitoring and suggest process modifications; maintain unified investigation procedures; collaborate on problem-solving using scientific principles; adhere to GxP regulations and maintain accurate documentation.
Seniority
Associate II, entry-to-mid level IC
