Quality Engineer
Core
Ensure compliance with FDA/GMP/QSR and ISO standards for medical devices, managing quality systems, audits, and corrective actions.
Role type
Quality Engineer (Medical Devices/Regulatory)
Builds
Quality Management Systems (QMS), validated manufacturing processes, and compliant medical device products
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA/GMP/QSR/ISO 13485 knowledge, CAPA management, root cause analysis, Six Sigma, Lean, statistical analysis, process validation, risk management (ISO 14971), supplier corrective action management
Preferred skills
ASQ certification, IEC 60601-1 knowledge, MS Word/Excel proficiency
Technologies
Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Whys
Responsibilities
Manage CAPA efforts and conduct investigations, execute New Product Introduction/Design Transfer activities, conduct internal audits and gap analyses, coordinate Supplier Corrective Action Requests (SCAR), analyze quality data for periodic reviews, participate in external audits, spend time on manufacturing floor for process improvements
Seniority
Mid-level, hands-on IC