Doc Control Analyst 2 CR (Temporal 6 meses)

•   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    

•     Summary 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.
•    Summary 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
•    Summary 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