Principal Engineer, Quality
Core
Lead quality engineering and manufacturing process optimization for cardiovascular medical devices, ensuring regulatory compliance and continuous improvement.
Role type
Principal Engineer, Quality (Manufacturing & Supply Chain)
Builds
Optimized manufacturing processes, validated device production, and compliant distribution systems for cardiovascular patients.
Domain
Medical Devices / Cardiovascular / Manufacturing Quality
Required skills
Quality Engineering principles, Six Sigma, LEAN, Risk Management, Supplier Quality, CAPA investigation, Statistical techniques, Engineering degree
Preferred skills
MS Office Suite, Technical drawing interpretation, CQE body of knowledge, Advanced problem-solving, Leadership, Change management
Technologies
None explicitly stated
Responsibilities
Lead identification and optimization of complex manufacturing processes using engineering methods; Oversee quality support tasks and train engineers/technicians; Drive development and execution of complex experiments and tests; Develop training and documentation materials for production; Lead investigation of complex manufacturing product quality and compliance issues; Manage Supplier Quality Activities.
Seniority
Principal, hands-on IC with strategic oversight