Process Quality Engineer
Core
Implement process control systems and lead quality investigations to ensure manufacturing of vascular medical devices meets regulatory and internal requirements.
Role type
Process Quality Engineer
Builds
Drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters, vessel closure devices, and peripheral stents
Domain
Healthcare / Medical Devices / Vascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process control systems, Quality tools/methodologies, FDA regulations, GMP, ISO 13485, ISO 14971, CAPA management, Six Sigma, Lean Manufacturing, Risk analysis, Product verification and validation
Preferred skills
Third Party Manufacturer (TPM) experience, Statistical/data analysis, Technical report writing, Certified Quality Engineer Accreditation
Technologies
None explicitly stated
Responsibilities
Identify and implement effective process control systems, Support investigation and resolution of product and process nonconformances, Lead process control and monitoring of Critical To Quality (CTQ) parameters, Lead and implement product and process improvement methodologies, Participate in or lead teams in supporting quality disciplines, Lead in the completion and maintenance of risk analysis, Work with design engineering on commercial product readiness and transfer to manufacturing
Seniority
Mid-level, hands-on IC