Ingeniero de Procesos
Core
Ensuring storage and distribution documentation remains updated, accurate, and compliant with established standards.
Role type
Process Engineer (Quality & Compliance)
Builds
Warehouse and distribution operations
Domain
Healthcare / Pharmaceutical / Medical Devices
Required skills
Quality management systems, Regulatory compliance, Process improvement, Risk assessment, Change control, FMEA, Validation protocols, Non-conformance analysis, Complaint handling, Training coordination
Preferred skills
Lean tools (Fishbone, Ishikawa, 5 Whys), English (Intermediate)
Technologies
ISO 9001, ISO 13485, COFEPRIS
Responsibilities
Verify compliance with COFEPRIS, ISO 9001, ISO 13485, and corporate requirements; Implement and monitor quality and compliance policies; Identify regulatory risks and propose mitigation actions; Review and update procedures and documentation; Manage validation/qualification protocols for equipment, areas, and computerized systems; Lead change controls and FMEA analysis; Prepare for and coordinate audits; Analyze non-conformities; Track product and service complaints; Coordinate staff training and qualification.
Seniority
Junior to Mid-level