Product Field Action (PFA) Lead, (Hybrid)
Core
Senior quality and post-market leader overseeing Product Field Action Assessments (PFAA), Nonconformance (NC), and Corrective and Preventive Action (CAPA) processes to protect patient safety and ensure regulatory compliance.
Role type
Senior IC quality and post-market leader (medical devices)
Builds
Compliant execution of field actions and risk mitigation strategies for emergency care products
Domain
Medical devices / Emergency Care / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (8D, Fault Tree Analysis), statistical analysis, risk-based methodologies, regulatory compliance (FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971), cross-functional leadership, audit support
Preferred skills
Product Field Action (PFA) experience, post-market quality processes, project management, quality and project management systems (TrackWise, SharePoint, Visio)
Technologies
TrackWise, Microsoft Office Suite, SharePoint, Visio
Responsibilities
Establish standardized processes for field action assessments and executions; Lead and provide strategic direction to Senior QA Engineers; Lead monthly PFA Board reviews; Identify and mitigate risks associated with field action decisions; Mentor and coach teams on risk management and investigation rigor; Support internal and external audit activities; Serve as the site voice in divisional and global meetings
Seniority
Senior, hands-on IC with strategic direction