Quality Engineer
Core
Investigate and resolve product, process, and manufacturing quality issues in a regulated medical device environment using structured problem-solving methodologies.
Role type
Quality Engineer (Manufacturing)
Builds
High-quality components for dialysis therapy (bloodlines, tubing systems, accessories)
Domain
Medical device manufacturing / Kidney care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, nonconformance management, statistical process control (SPC), process capability analysis, Pareto analysis, trend analysis, measurement system analysis, FMEA, risk management, process validation, equipment qualification, cross-functional collaboration
Preferred skills
Lean Six Sigma Green Belt, ISO 13485, ISO 14971, process validation, equipment qualification, manufacturing transfers, extrusion, injection molding, automation, assembly processes
Technologies
Minitab, Microsoft Office
Responsibilities
Investigate and resolve quality issues using 8D, 5 Why, Fishbone, and Root Cause Analysis; Execute CAPA, nonconformance, deviation, and corrective action activities; Analyze quality and manufacturing data to identify trends and opportunities for improvement; Provide technical support for customer complaint investigations; Apply statistical quality tools to support data-driven decision-making; Participate in continuous improvement initiatives focused on defect prevention and variation reduction; Support new product introductions, design changes, and manufacturing transfer projects; Contribute to risk management activities including FMEA and validation; Collaborate with Manufacturing, Process Engineering, Operations, Supply Chain, Regulatory Affairs, and Quality teams; Ensure compliance with ISO 13485 and ISO 14971; Support internal and external audits; Promote best practices and knowledge sharing across manufacturing sites.
