(Senior) Quality Engineer (m/f/d)
Core
Supporting operational production areas by ensuring quality standards for medical implants and instruments through project execution, machine validation, and process improvement.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Medical implants and instruments
Domain
Medical device manufacturing / Regulated industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Machine commissioning and qualification, Process risk analysis, Change management, NC/CAPA implementation, Work instruction creation, Project management, MS Office, Process control planning
Preferred skills
Cleanroom packaging experience, Q-methods (MSA, PPAP, FMEA), CAQ systems (Babtec), Trackwise, Windchill 11
Technologies
MS Office, Windchill 11, Trackwise, Babtec
Responsibilities
Commissioning and qualifying machines for series production, Analyzing quality deviations and implementing corrective actions, Creating work and inspection instructions, Conducting process risk analyses, Collaborating with production and engineering departments, Ensuring project delivery within quality standards and timelines
Seniority
Senior, hands-on IC
