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