Product Complaints Specialist
Core
Execute product complaint management, investigation, and servicing requests for medical devices, ensuring accurate documentation, tracking, and reporting per regulatory requirements.
Role type
Senior Product Complaints Specialist (Post-Market Surveillance)
Builds
Complaint records, investigation reports, KPI dashboards, and trend analyses for ANZ region quality management.
Domain
Healthcare / Medical Devices / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Medical device complaint handling, Quality systems (21 CFR Part 820, ISO 13485), Data analysis and trending, Regulatory compliance, Workflow coordination, Stakeholder communication
Preferred skills
ERP systems, Power BI, Power Apps, CAPA management, Change management, ANZ regional regulatory knowledge
Technologies
MS Office (Word, Excel, PowerPoint, Outlook), Power Apps, Power BI
Responsibilities
Receive and review incoming product complaint submissions; Coordinate complaint workflow activities and follow-up schedules; Support investigation activities by collecting evidence and monitoring completion; Prepare monthly complaint KPI reports and trend analyses; Ensure compliance with record retention and quality system procedures.
Seniority
Senior, hands-on IC