PMS Quality Engineer
Core
Process complaint investigations, drive root cause analyses, and execute continuous quality improvement programs for medical devices to ensure regulatory compliance and product safety.
Role type
Senior Quality Engineer (Post Market Surveillance)
Builds
Closed-loop quality management systems and robust resolution processes for field product issues
Domain
Medical Device / Regulatory Quality / Post Market Surveillance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
complaint investigation, root cause analysis, cross-functional collaboration, technical writing, data analysis, process improvement, regulatory compliance, problem solving
Preferred skills
Quality Systems Regulations (21 CFR 820, ISO 13485), Lean/Six Sigma methodologies, Project Management
Technologies
QMS systems, data analysis tools
Responsibilities
Process complaint investigations, partner on escalated field events and regulatory responses, evolve processes for timely issue escalation, collect and analyze data for improvement strategies, participate in internal/external audits
Seniority
Senior, hands-on IC