Staff Quality Engineer
Core
Provide quality leadership and oversight for manufacturing processes, product quality, and regulatory compliance in a medical device environment.
Role type
Staff Quality Engineer (Manufacturing)
Builds
compliant medical device products and robust quality systems
Domain
Medical Device Manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA management, Root Cause Analysis, Risk Management, Audit leadership, Validation, Statistical sampling, Process capability analysis, Supplier quality oversight, Change management, Material Review Board (MRB) processes
Preferred skills
Lean Six Sigma, Human Error Prevention, Regulatory agency interaction, Manufacturing transfer management, GD&T and inspection method development
Technologies
ISO 13485, GMP, FDA regulations, Statistical software, Quality management systems
Responsibilities
Lead investigations and resolution of nonconformances (NCs) and drive corrective and preventive actions (CAPAs). Partner with Operations, Engineering, and Supply Chain to ensure compliance with quality systems. Analyze quality metrics and KPI trends to drive continuous improvement. Lead internal, external, customer, supplier, and regulatory audits. Support validation strategies and manufacturing transfers. Coach and mentor quality professionals on quality systems and problem-solving methodologies.
Seniority
Staff, hands-on IC with strategic influence