Quality Engineer II
Core
Ensuring product quality, regulatory compliance, and continuous improvement in a regulated medical device manufacturing environment.
Role type
Quality Engineer II (Medical Device Manufacturing)
Builds
Disposable medical products for dialysis treatments (hemodialysis disposables, PD disposables, HD/PD cycler machines)
Domain
Healthcare / Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk assessment (FMEA, FMECA, Fault Tree Analysis, Hazard Analysis), Process validation (IQ/OQ/PQ), Root cause analysis, Statistical analysis (DOE, Correlation & Regression, Acceptance Sampling, Gage R&R), Process capability studies, Technical writing, Engineering drawing interpretation
Preferred skills
Advanced degree, German language proficiency
Technologies
Minitab, SAP
Responsibilities
Support quality initiatives, compliance objectives, and quality planning; Participate in internal and external audits; Support design control activities; Conduct risk assessments; Lead and support process and test method validations; Develop and maintain quality documentation; Perform root cause analysis and continuous improvement activities; Conduct and interpret statistical analyses; Ensure compliance with regulatory requirements; Support cross-functional quality projects
Seniority
Mid-level IC (2-5 years experience)
