Job Description

• Education / Educación:

• Be actively studying and have completed at least 50% of the bachelor's degree in engineering, management or equivalent related fields: Accredited Technical Certification, minimum (350 hours).

• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
• Experience in a medical device company preferred.
• Knowledgeable in document control system (Change Control)

• Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
• Spanish / English Advanced (Writing-Listening-Reading)

• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:

• Microsoft Office: Advanced

• of Duties and Responsibilities / Resumen de funciones y responsabilidades:
• Provide support to the Engineering Services Professional in any assigned management.
• Lead, propose, develop and implement continues improvement activities/projects related to the Documentation (Doc Control/DHR) area.
• Adequately use the technological tools adopted by the company to achieve positive results for the organization.
• Actively comply with the organizational values in order to maintain a positive working environment.
• Participate and actively support all Documentation Area services related tasks and responsibilities for new product/process transfers, as required.
• Understand and implement the quality system procedures that are related to allocate responsibilities to the position and / or Document Control department.
• Actively meet the defined organizational values, in order to maintain a positive work.
• of Duties and Responsibilities (Change Control Emphasis)
• Responsible for implementing and maintaining an engineering change order system. These changes will include product improvements, repairs, and new product release.
• Responsible for the interface between Engineering, Operations, Customer Service, Marketing, etc., to ensure the appropriate changes are properly documented.
• Work with change order originators to write change orders and other related change documents.
• Track and coordinate change order development, approval, and implementation.
• Support change order originators with non-technical aspects of change orders, including material disposition and implementation of follow-up actions required.
• Follows standard practices and procedures when analyzing situations or data. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• May perform some engineering clerical work such as filing, materials requisition and correspondence.
• Ensures that existing procedures and standards are followed.
• May include other duties as defined by the Engineering Services department management
• of Duties and Responsibilities (DHR Department)
• Review the precision for all the DHR's documentation including subassemblies and finished goods to guarantee compliance with procedures.
• Review of sterile loads and pre-sterile material base on procedures applicable to each product, before of the release of that material according to the release procedure.
• Review the procedures related to this position to improve and optimize standardization and continuous improvement.
• Generate NCE's as required and ensure the correct segregation and identification for non-conforming material according to the procedures established in the Quality Management system.
• Maintain constant communication with Supply Chain, production and microbiology personnel to deal with issues related to DHR's and the release of the finished product.
• Generate and update traceability reports and metrics of documentation errors.
• Comply with all policies and internal rules of the organization, and those stipulated in the quality system.
• Support the programming of the tasks performed by the documentation personnel during their workday to ensure a balance in the workload assigned to the collaborators

• Qualifications / Cualificaciones:
• Customer service skills
• Problem Solving
• Drive for results