Senior Manager, RDQA
Core
Senior Manager leading R&D Device Quality, providing direction on design control, human factors/usability engineering, and risk management processes for medical device and combination product development.
Role type
Senior Manager, R&D Device Quality
Builds
Medical devices and device components of combination products
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control system establishment, Human factors/usability engineering, Risk management (FMEA, hazard analysis), FDA QSR 21 CFR Part 820 compliance, ISO 13485 compliance, Root cause analysis, Design for manufacturability, Clinical batch manufacturing oversight, CAPA investigations, Regulatory audit support, Requirements analysis, Reliability analysis
Preferred skills
MS in Engineering or Scientific discipline, Project management experience, Experience with combination products, Experience with Canadian Medical Device Regulation (SOR 98-282), Experience with IEC/EN 62366 and ANSI HE75 standards
Technologies
FMEA, DOE, Statistical process control, CTQ development, VOC analysis
Responsibilities
Provide quality system methodology guidance for design and development processes; Assess design documentation for quality characteristics including safety and manufacturability; Translate design requirements into manufacturing requirements; Lead design and reliability activities (DRM practices); Ensure compliance with FDA, ISO, and other applicable standards; Provide quality oversight for clinical batch manufacturing; Develop and implement site QA strategies; Support regulatory audits and inspections.
Seniority
Senior Manager, strategic direction & cross-functional leadership
