Doc Control Analyst 2 CR

Hologic Inc.
Amsterdam, Netherlands
13 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English, Spanish

Job location

Amsterdam, Netherlands

Tech stack

Document Management Systems
Microsoft Office
Workday

Job description

  • 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

Requirements

  • 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, * Customer service skills

  • Problem Solving

  • Drive for results

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