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This is a full-time position to work in our Heredia site, located in Zona Franca Metropolitana. Remote work might be available based on business needs.

Our Quality Engineer Assistants shall work with Manufacturing, Quality, Production, Administrative and Technical personnel of the campus to gather and provide information required by Engineering as required to ensure the achievement of expected quality levels, customer satisfaction & financial goals. Provide Quality Engineering/Quality Systems Engineering support to improvement of the quality system and compliance in order to ensure the development and production of Class I, II and III (as applicable) Medical Devices.

• Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations, Test Method Validation (TMV) protocols drafting and/or its execution for the purpose of equipment verification, supported by a Quality Engineer.
• Represent Quality in production process efforts, support the team on FMEA and risk analysis, support new product development activities, maintain and manage quality compliance and supplier quality management, support and collect data for any complaint investigations, NCs or CAPA, collaborate on process improvement and quality assurance testing metrology.
• Participate in Corrective/ Preventive Action, NC investigation and Complaints initiatives supported by Quality Engineer

Main Job Duties/Responsibilities

• Collect process data for TMVs to assist in transfer, training, validation or other project related works under the guidance of a Quality Engineer.
• Perform inventories whenever prompted (Quality Cages).
• Create Component Specification and Item Master.
• Create First Article Inspections.
• Execute initiation of NC and Complaints as needed
• Support in the execution of qualifications (TMVs) with an approved protocol, gather data and results for completing the corresponding report, under the guidance of a Quality Engineer.

Knowledge / Education / Experience

• 3 years in a highly regulated manufacturing environment (medical devices) occupying positions of growing responsibilities.
• High School Diploma
• Studying an Engineering, Technical related career or Science (such as Pharmacy, Microbiology, Physics and Chemistry)
• Intermediate knowledge of Microsoft Office package (Word, Excel, Power Point and Outlook).
• Knowledge on ISO 13485:2016 and CFR 820 CGMPs
• Intermediate English is a must, able to understand, speak and write in English.

Viant es un proveedor global de servicios de diseño y fabricación de dispositivos médicos que se asocia e innova con los clientes para proporcionar la más alta calidad, dispositivos médicos que mejoran la vida de las personas. Hacemos esto a través de nuestra profundidad y amplitud de capacidades, integración de extremo a extremo, experiencia técnica y enfoque implacable en nuestros clientes y en la excelencia operativa. Con casi 6.000 asociados en 24 ubicaciones en todo el mundo, ofrecemos una combinación única de servicio y atención a pequeñas empresas con recursos de grandes empresas. Para más información, visite viantmedical.com o síganos en LinkedIn.

Viant proporciona igualdad de oportunidades de empleo (EEO) a todos los empleados y solicitantes de empleo sin tener en cuenta la raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, estado civil, amnistía, o estatus como veterano cubierto de acuerdo con las leyes federales, estatales y locales aplicables. Viant cumple con las leyes estatales y locales aplicables que rigen la no discriminación en el empleo en todos los lugares en los que la empresa tiene instalaciones.