Principal Quality Engineer
Core
Establish and maintain quality engineering methodologies, systems, and practices for medical devices, specifically hepatic artery infusion pumps, ensuring compliance with regulatory requirements.
Role type
Principal Quality Engineer (Medical Devices)
Builds
Quality systems, risk management plans, and process controls for medical device product development and manufacturing.
Domain
Medical Devices / Regulatory Compliance
Required skills
Risk management (ISO 14971), FMEA, CAPA management, Design controls, Process validation, Root cause analysis, Regulatory compliance, Quality system design, Cross-functional leadership, Technical mentoring
Preferred skills
None stated
Technologies
ISO 14971, FMEA, CAPA, Design Control Systems
Responsibilities
Apply advanced quality engineering principles to assigned products and processes; Champion cross-functional engineering initiatives; Proactively identify and implement best-in-class quality practices; Develop and implement process and design control systems; Serve as SME in applying ISO 14971 risk management principles; Lead or review risk management plans, hazard analyses, and FMEAs; Assess implementation and effectiveness of risk control measures; Evaluate new information from complaints and post-market surveillance; Lead continuous improvement of quality assurance processes.
Seniority
Principal, hands-on IC with mentorship