Ingeniero Senior de Calidad
Core
Senior Quality Engineer leading complex technical activities in regulatory compliance, validation, risk analysis, and process improvement for medical devices/pharmaceuticals.
Role type
Senior IC Quality Engineer (Medical Devices/Pharma)
Builds
Validated processes, compliant products, and robust quality systems for medical device manufacturing.
Domain
Medical Devices / Pharmaceuticals / Regulatory Quality
Required skills
CAPA execution, Risk Analysis, Equipment/Process Validation, Root Cause Analysis, Statistical Tools (SPC, MSA, DOE, Cp/Cpk), Minitab, ISO 13485, 21 CFR Part 820, ISO 14971, Technical Drawing Interpretation
Preferred skills
Six Sigma, Lean, Kaizen, FMEA, DOE, Statistical Software, Change Control (ECO/CN), Supplier Quality Management
Technologies
Minitab, Office Suite (Word, Excel, PowerPoint)
Responsibilities
Ensure compliance with ISO 13485, 21 CFR Part 820, and ISO 14971; Lead process validation (IQ/OQ/PQ) and equipment validation; Manage complex CAPAs, SCARs, and non-conformities; Conduct advanced statistical studies (MSA, SPC, DOE); Lead customer complaint investigations and supplier quality management; Mentor junior quality engineers and technicians; Drive Lean/Six Sigma projects for process efficiency.
Seniority
Senior, hands-on IC