Product Quality Engineer (w/m/d)
Core
Ensuring product quality and regulatory compliance for medical devices throughout the development and production lifecycle.
Role type
Product Quality Engineer
Builds
Medical device products for surgical and critical care applications
Domain
Medical Technology / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk analysis (FMEA, 8D, A3, 5 Why, Ishikawa), Quality documentation management, Change control validation, Test planning and execution, Regulatory compliance knowledge, Technical documentation proficiency
Preferred skills
Experience in medical device industry, Knowledge of PDCA and Pareto analysis, Structured presentation of analysis results
Technologies
Design History File, FMEA tools, Risk management software
Responsibilities
Create and maintain quality documentation (e.g., Design History File), Conduct risk analyses for medical devices, Support FMEA activities in development and production, Evaluate product change requests, Plan and execute component and product tests, Define and validate test equipment, Escalate and resolve quality issues, Document and report risks and malfunctions, Ensure compliance with national and international medical device regulations
Seniority
Mid-Senior, hands-on IC
