Quality Engineer II- Medical Devices
Core
Ensure product quality and process compliance for medical device manufacturing operations through engineering principles and quality tools.
Role type
Quality Engineer II (Manufacturing)
Builds
Robust quality systems and compliant manufacturing processes for medical devices
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (8D, 5 Whys, Fishbone), Statistical Process Control (SPC), Measurement Systems Analysis (MSA), Quality Management Systems (ISO 9001, ISO 13485, IATF 16949), Design review input, Supplier quality audits, Data analysis for trends
Preferred skills
Six Sigma Green Belt, Supplier Quality experience, Injection molding knowledge
Technologies
Microsoft Office Suite (Excel, Word, PowerPoint)
Responsibilities
Develop and maintain quality control plans, Conduct root cause analysis and implement CAPA, Perform statistical analysis of process data, Participate in design reviews, Support supplier quality audits and qualification, Lead internal and external audits, Train junior quality personnel, Prepare quality performance reports
Seniority
Mid-level, hands-on IC