Senior Engineer, Quality
Core
Manufacturing Sustaining Quality Engineer supporting valve operations (RESILIA processing, sterilization, packaging) to ensure regulatory compliance and optimize product development.
Role type
Senior IC Quality Engineer (Manufacturing Sustaining)
Builds
Medical devices (structural heart valves)
Domain
Medical Devices / Structural Heart
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality engineering principles, Six Sigma, Lean, risk management, technical documentation, equipment design/re-design, team leadership
Preferred skills
Statistical techniques, laboratory/industrial equipment operation, MS Office Suite
Technologies
RESILIA processing systems, sterilization equipment, packaging machinery
Responsibilities
Investigate complex product quality and compliance issues (CAPA, non-conformances, audit observations); Optimize complex manufacturing processes using quality engineering methods; Identify opportunities to design or re-design equipment, tools, and fixtures; Develop, update, and maintain risk management files; Create training and documentation materials for production; Assign support tasks and provide direction to technicians; Train, coach, and guide lower-level employees on routine procedures
Seniority
Senior, hands-on IC with mentorship responsibilities