2nd shift Quality Engineer II
Core
Ensure manufacturing processes meet production schedules and product quality for commercially released electrophysiology devices.
Role type
Quality Engineer II (Manufacturing)
Builds
Medical devices for heart disease treatment (atrial fibrillation)
Domain
Healthcare / Medical Devices / Electrophysiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulations, GMP, ISO 13485, ISO 14971, process control systems, CAPA systems, Six Sigma, Lean Manufacturing, risk analysis, experiment design
Preferred skills
medical device experience, CAPA ownership
Technologies
None explicitly stated
Responsibilities
Identify and implement process control systems; lead implementation of assurances and CAPA systems; design and conduct experiments for process optimization; document experiment plans and results; lead process control and monitoring of CTQ parameters; lead investigation and prevention of non-conformances; support Quality Management Systems and regulatory requirements.
Seniority
Mid-level IC
