Document Change Management Specialist

hace 3 días


San Francisco, Heredia, Costa Rica Aligntech A tiempo completo

**Job Overview**

We are seeking a highly skilled and experienced individual to join our Global Document Services team as an Administrator, Global Document Services.

This is a global role responsible for driving document change and record control process.

The Administrator, Global Document Services forms part of the Global QMS Team, reporting directly to the Senior Manager, Global Quality Services.

This role involves:

  • Executing the global document change management and control processes for the different company sites around the world.
  • Processing change requests and change orders for quality management system documents.
  • Supporting the development and configuration of the global document change control software.
  • Assisting in the definition and implementation of standardized metrics and KPIs to facilitate process governance.

**Responsibilities**

The key responsibilities of this role include:

  • Managing document changes involving quality management system documents belonging to Align sites around the globe.
  • Maintaining documentation systems to ensure full compliance with Medical Device Regulations.
  • Managing changes to multiple documents with a change order so they are reviewed, approved and made current as a synchronized group, when applicable.
  • Facilitating the document approval process to change current content with change requests.
  • Supporting adequate documentation of reason for change.
  • Maintaining default routings for different categories of changes.
  • Supporting the creation/review and maintenance of document approval matrixes.
  • Managing/process changes to the PLM system product structures/ process routings.
  • May also be in charge of sustaining, coordinating and maintaining the quality management system document training assignment.
  • May collaborate with other internal groups to respond to product inquiries and issues.

**Requirements**

To be successful in this role, you should have:

  • From 2 to 6 years of medical device (or similar highly regulated) industry experience.
  • University Bachelor Degree or in the process of finishing (over 80% completed).
  • Experience in managing document control processes as required by ISO13485, ISO14971 and FDA 21CFR part 820 aligned systems/processes.
  • Comfortable engaging and communicating with other sites within the company around the globe.
  • Internal and external audit Experience is a plus.
  • Experienced with and in coordinating the use of electronic quality system document control software.


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