Supplier Quality Engineer
Core
Ensure robust materials, products, processes, and systems for suppliers in a medical technology environment.
Role type
Supplier Quality Engineer
Builds
Supplier quality systems, corrective actions, and risk control processes
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, supplier auditing, quality data analysis, change management, project management, Quality Engineering tools (FMEA, SPC, MSA, DOE), regulatory compliance (21 CFR 820, ISO 13485, ISO 14971), technical writing
Preferred skills
Advanced degree, Certified Lead Auditor (ISO 13485), new product introduction experience, FDA inspection experience
Technologies
PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP
Responsibilities
Collaborate with suppliers to ensure robust materials and processes; support root cause investigations and drive corrective actions; manage and escalate supplier issues; plan and execute supplier quality audits; monitor supplier performance metrics; implement supplier change management; lead SQM projects; analyze quality data to identify trends; prepare Supplier Quality Agreements; develop Quality Risk Management processes; lead component qualification change projects.
Seniority
Mid-Senior, hands-on IC
