Doc Control Analyst 2 CR (L-S 2pm a 10pm) (Temporal 12 meses)

Costa Rica·Alajuelamid

OtherAnalyst

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Quick Summary

Key Responsibilities

Provide support to the Engineering Services Professional in any assigned management. Lead, propose,

Requirements Summary

Customer service skills Problem Solving Drive for results

Technical Tools

OtherAnalyst

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