Principal Quality Engineer
Core
Technical lead for complaint investigations and CAPA (Corrective and Preventive Action) in a regulated medical device environment, serving as a liaison between Quality, R&D, and Operations.
Role type
Principal Quality Engineer (Regulatory/Quality Systems)
Builds
Investigation processes, test methods for root cause analysis, and global quality standards/specifications.
Domain
Medical Devices / Healthcare / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, regulatory compliance (FDA/ISO), data analysis, test method development, cross-functional liaison, project management
Preferred skills
Team leadership, coaching, strategic planning, process improvement
Technologies
None explicitly stated
Responsibilities
Lead large CAPA investigations and develop test methods to identify root causes; implement and maintain the effectiveness of the quality system; set global standards for specifications and drawings; translate business strategy into quality objectives; ensure compliance with regulations regarding complaint investigations.
Seniority
Principal, hands-on IC with strategic oversight
