Senior Quality Engineer - Complaints Handling
Core
Handling complaints and investigating product failures for medical devices, including root cause analysis and risk assessment.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Complaint files, PMS plans, PSUR reports, and trend analysis for regulatory compliance.
Domain
Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, 7 QC tools, CAPA, Risk management (ISO 14971), Process flow review, Inspection planning, Measurement techniques, GRR analysis, Clinical report review, PMCF report analysis, National register analysis, PMS plan creation, PSUR report creation, Trend report generation, Process improvement, Workflow redesign.
Preferred skills
Medical device complaint handling process knowledge, GDP knowledge, ISO 9001 knowledge, ISO 13485 knowledge, FDA 21CFR Part 822/820 knowledge, Stakeholder engagement, Cross-functional collaboration, Mentorship, Team leadership.
Technologies
ISO 14971, ISO 9001, ISO 13485, FDA 21CFR Part 822/820, GDP, 7 QC tools, GRR
Responsibilities
Perform visual, functional, and dimensional inspections of field returned products; Conduct risk assessments and root cause analysis; Review process flows, DHRs, and inspection plans; Create and analyze PMS, PSUR, and trend reports; Identify opportunities for process improvement and workflow redesign; Mentor and develop team members.
Seniority
Senior, hands-on IC with mentorship responsibilities