Ingeniero De Calidad

The Quality Engineer is responsible for maintaining the effectiveness of the Quality Management System and overseeing all aspects of quality, including First Article Inspections, capability studies, DOE (Design of Experiments), procedure development, root cause analysis, corrective and preventive actions, and all other areas of quality control programs in a GMP and ISO 13485 environment.ResponsabilidadesEnsures compliance with customer quality specifications throughout the manufacturing process and final product.Ensures compliance with internal procedures and work instructions throughout the manufacturing process and final product.Prepares reports and formats necessary to document customer specifications regarding manufacturing processes and final products.Creates and updates Quality documents required to maintain the Quality System.Reviews and approves documentation in the IQMS system created or updated by other departments to support process sustainabilityActively participates in and documents investigations and resolutions of NCMRs, customer complaints, CARs, CAPAs, and SCARs.Follows up on the implementation plan and filing of corrective and preventive actions.Acts as a subject matter expert for risk management validation, regulatory training, compliance, and CAPA execution.Ensures regulatory compliance and adherence to internal and external specifications and standards, such as GMP and ISO.Participates in the review, manufacturing, and testing of new products to ensure quality requirements are metServes as a liaison with customers, suppliers, and external consultants as needed.Ensures proper use and calibration of measuring devices, calipers, micrometers, according to assigned processes.Follows up on material disposition in the MRB areaAssists in troubleshooting equipment issues using statistical data and supporting information as needed.Coordinates timely analysis and closure of CAPA / CAR.Leads special projects for the Quality department as needed.Supports new product development by creating and executing process validation protocols.Supports new product development through the creation and execution of TMVs, NPI Checklists, Drawings, Control Plans, and FMEAs.Negotiates responsibility terms with customers when agreements have been breached or conditions disregarded.Develops and implements performance improvement ideas and reporting tools across departments.Responsible for self-training on applicable procedures and work instructions.Actively participates in internal and external audits.Serves as a guide for the development of activities by other engineers and / or departments.Responsible for self-training on applicable procedures and work instructions.May perform additional activities assigned by their supervisor or team lead if required.RequisitosDegree in Engineering or a field related to the medical industryGreen belt certificationPrevious experience as a Quality Engineer in the medical device industryExperience in the medical industry (ISO 13485, CFR 820) or other regulated industriesExperience as an internal auditor for ISO 13485Knowledge of medical industry regulations (FDA CFR 820, GMPs, ISO 13485, etcProblem-solving methodologies (PDCA, DMAIC, 8D, RCA, etc.)Proficient in Microsoft Office (Word, Excel, PowerPoint, Project)Experience using Minitab (Applied Statistics)Validation processes : IQ, OQ, PQUnderstanding of cleanroom operations and criteriaKnowledge of Six Sigma and Lean Manufacturing methodologiesEnglish language