Quality Engineer
Core
Monitoring and improving quality performance for medical devices using statistical process control and data-driven metrics to ensure process stability and continuous improvement.
Role type
Quality Engineer (Manufacturing)
Builds
Medical devices and manufacturing processes
Domain
Medical Devices / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical Process Control (SPC), Six Sigma (DMAIC, 5 Why, Fishbone, 8D), Measurement System Analysis (MSA), Gage R&R, Root Cause Analysis, Validation Planning, Risk Management (PFMEA, DFMEA), Process Capability Analysis (Cp, Cpk), Design of Experiments (DOE), Regulatory Compliance (GDP)
Preferred skills
Lean Six Sigma Green Belt certification, CAPA ownership, Statistical data analysis, Design transfer processes
Technologies
None explicitly stated
Responsibilities
Act as Quality Lead for a specific Manufacturing Value Stream; Provide day-to-day quality engineering support to manufacturing; Lead structured root cause analysis using Six Sigma and Lean tools; Assist in establishing and maintaining process controls and inspection plans; Conduct Measurement System Analysis (MSA) including Gage R&R studies; Use statistical analysis to identify trends and recommend preventive actions; Support change control including risk assessments and documentation review; Evaluate quality impact of product and process changes; Support readiness activities for new products/processes; Maintain risk management files (PFMEA, DFMEA); Develop and execute validation plans and protocols; Perform process capability analysis and contribute to DOE; Act as subject matter expert during audits; Lead or contribute to CAPA initiatives; Ensure excellent documentation aligned with GDP; Collect and interpret quality performance data; Prepare and present quality metrics to stakeholders; Lead Six Sigma-based continuous improvement projects; Conduct investigations into returned products and customer complaints; Collaborate with suppliers, test labs, and engineering functions.
Seniority
Mid-level (2–5 years experience required)