Descripción y detalle de las actividadesSupport the Post Market Surveiilance organization in the investigation and corrective actions associated to customer complaints for the business it supports. Participates in root cause investigations, correction, corrective actions, and definition of effectiveness for complaint reports, trending, and escalations. Understands product's intended use and field practices and procedures as well as production processes and distribution activities related to the products supported. Is familiar in the practical and regulatory requirements related to product and process risk management. Collaborates directly with all relevant supply chain and comercial partners May have personnel under their supervisión to analyze complaint simples as a first line of support.Experiencia y requisitos• Investigates complaint reports associated to manufacturing process and product characteristics.• Represents the organization at Daily management meetings to provide or request support relevant to on-time investigations.• Coordinates producto return samples for análisis and prioritization.• Represents the site and producto families in fórums with different áreas of the organization and may communicate directly with customers.• Leads corrective action effectiveness checks with the supply chain and other aplicable teams, and ensures on-time root cause analysis, corrective action implementation, and quality complaints closure.• Trains and communicates with all levels of the organization, including line personnel to educate and inform on the impact of following process instructions.• Certified Quality Engineer (preferred)• Certified Six Sigma Green belt (preffered)• Knowledge of medical device industry requirements and regulations such as ISO13485, FDA 820, FDA 806, FDA 803.• Strong Root Cause analysis skills• General understanding of Statistics including statistical process controls, ANOVA, DOE studies.• Strong understanding of sampling plan determination, process capability, and process improvement tools.• Experience with process improvement disciplines such as kaizen.General understanding of materials characteristics• Atención al detalle, además de habilidades de organización. • Buenas habilidades interpersonales y de liderazgo.• Emprendedor/a y puede trabajar con supervisión mínima.Collaborative mindset.• Represents Corza Medical value.• Able to communicate effectively.• Can present information in an orderly fashion and convey results in a manner that drives action..-2 to 4 years of experience -Completed Engineering -Advanced English.
