Principal Engineer, Supplier Quality
Core
Leading and supporting quality improvements and resolution of daily quality issues for medical device manufacturing, including raw material and service quality planning, evaluation, and control.
Role type
Principal Engineer, Supplier Quality
Builds
Medical device products (infusion sets, suction tubing, drainage bags, enteral feeding, connecting tubes) using PVC resin, components, and packaging.
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification and risk management, Advanced Quality Planning (APQP), FMEA, statistical analysis, CAPA process management, QMS compliance, cross-functional stakeholder coordination, problem-solving methodologies, data analysis for process improvement.
Preferred skills
ISO 13485 knowledge, Power BI, VLOOKUP, reliability and maintainability analysis.
Technologies
Microsoft Excel (advanced), Power BI, FMEA tools, QMS software.
Responsibilities
Identify supplier risk levels and complete qualification requirements; review processes to qualify raw materials and components; partner with suppliers to manage performance; develop and implement quality programs including tracking, analyzing, reporting, and problem solving; ensure compliance of QMS and follow up through CAPA; support product and process validations; drive continuous improvement activities on the production floor.
Seniority
Senior, hands-on IC with leadership responsibilities
