Quality Engineer II
Core
Ensure manufacturing processes meet production schedules and product quality for commercially released electrophysiology devices.
Role type
Quality Engineer II (Medical Devices)
Builds
Medical device manufacturing processes and quality assurance systems
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, experimental design
Preferred skills
Medical device experience, CAPA ownership
Technologies
Six Sigma, Lean Manufacturing
Responsibilities
Identify and implement effective process control systems; Lead implementation of assurances and CAPA systems; Assist in developing streamlined business systems for quality issues; Apply systematic problem-solving methodologies; Work with cross-functional teams to design and conduct experiments for process optimization; Lead process control and monitoring of CTQ parameters; Lead investigation and resolution of product and process non-conformances; Participate in risk analysis; Support Quality Management Systems and regulatory requirements.
Seniority
Mid-level IC
