2nd shift Quality Engineer II
Core
Ensure manufacturing processes meet production schedules and product quality for commercially released medical devices in the Electrophysiology division.
Role type
Quality Engineer II (Manufacturing)
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 knowledge, GMP compliance, 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 effective process control systems, lead implementation of assurances and process controls, assist in developing streamlined business systems for quality issues, apply systematic problem-solving methodologies, work with cross-functional teams to design and conduct experiments, document experiment plans and results, lead process control and monitoring of CTQ parameters, lead and implement product and process improvement methodologies, lead investigation and prevention of non-conformances, participate in quality disciplines and risk analysis, support QMS and regulatory requirements
Seniority
Mid-level IC