Quality Assurance Engineer, Intermediate
Core
Ensure delivery of high-quality, compliant vascular medical devices by driving continuous improvement, managing audits, and supporting new product introductions in a manufacturing environment.
Role type
Intermediate Quality Assurance Engineer (Manufacturing/Regulated)
Builds
Vascular care devices (vessel closure, endovascular, coronary technologies)
Domain
Medical Devices / Vascular Care / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, audit preparation and response, ISO and regulatory compliance review, Lean Six Sigma methodologies, FMEA, validation protocol writing, process monitoring
Preferred skills
New product introduction (NPI) experience, project leadership, mentoring junior staff
Technologies
Lean, Six Sigma, FMEA, process monitoring systems
Responsibilities
Identify and resolve manufacturing issues using structured root cause analysis; Lead and support CAPA processes and audit activities; Review processes to ensure alignment with ISO and regulatory standards; Collaborate on new product launches ensuring quality is built in; Contribute to continuous improvement projects using data-driven methodologies; Participate in validation activities including protocol writing and execution; Support Field Discrepancy Notification investigations
Seniority
Intermediate, hands-on IC with some mentorship