Quality Engineer
Core
Ensures product quality and process control in medical device manufacturing by investigating defects, leading continuous improvement projects, and ensuring regulatory compliance.
Role type
Quality Engineer (Manufacturing)
Builds
High-quality medical devices and compliant manufacturing processes
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FMEA, risk mitigation, plant validations, DOE, Six Sigma, Lean, root cause analysis, process capability studies, hazard analysis, internal audits, PIR/CFI investigations
Preferred skills
Medical device manufacturing experience, continuous improvement methodologies
Technologies
Six Sigma, Lean, FMEA, DOE
Responsibilities
Investigate and resolve quality-related manufacturing issues; lead Kaizen and continuous improvement projects; formulate and implement quality policies and procedures; coordinate communication between R&D and Plant personnel; perform internal audits and investigations; analyze process capability data and submit recommendations.
Seniority
Entry to Mid-level, hands-on IC
