Principal Quality Engineer - Management Review Owner
Core
Lead and manage quality projects, drive QMS improvements, and own the Management Review program to ensure regulatory compliance and efficient manufacturing.
Role type
Principal Quality Engineer (Management Review Owner)
Builds
Global quality system, management review dashboards, and inspection-ready documentation
Domain
Pharmaceutical manufacturing / Medical device engineering
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
QMS management, root cause analysis, risk management (FMEA, fault tree), ICH Q10 compliance, CAPA/Deviation/Change Control management, statistical data analysis, audit readiness, executive reporting
Preferred skills
10+ years pharma/medical device QA experience, FDA cGMP (21 CFR 210/211) and EU GMP expertise, managing disconnected data sources, inspection response experience
Technologies
FMEA, fault tree analysis, PowerPoint, statistical data collection tools
Responsibilities
Lead cross-functional quality projects and drive QMS efficiency; Own and maintain the Management Review program per ICH Q10; Analyze PQS performance data (deviations, CAPAs, complaints) and prepare trend reports; Facilitate management review meetings with site leadership; Manage risk assessment and mitigation for product/process projects; Ensure inspection readiness and regulatory compliance; Escalate significant quality and business risks to leadership
Seniority
Principal, hands-on IC with strategic oversight
