Global Document Services Administrator

hace 3 semanas


San Francisco, Heredia, Costa Rica AlignTech A tiempo completo

Join a team that is changing millions of lives.

  • Transforming smiles, changing lives_


At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next.

We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation.

Our diverse and collaborative teams are constantly pushing the boundaries of what's possible.

Ready to join us?

About this opportunity
Align is the industry leader and innovator in medical devices which focuses on revolutionizing the dental and orthodontic industry. Align, the makers of Invisalign is looking for an

Administrator, Global Document Services. This exciting new role will be part of a culture that is helping to improve lives every day through digital dentistry. The Administrator, Global Document Services role is part of the Global QMS Team, reporting directly to the Senior Manager, Global Quality Services. This global role is responsible for driving document change and record control process. This global is responsible for driving the document change process. This role is part of Align Technology goal to deliver the next generation of clear aligners (Invisalign) to our customers. We would love for you to join a fun and cutting-edge technology company that has helped create over 15 Million Smiles.

In this role, you will


This role provides advice and user support across the global business on the use of the global document change management process supporting the execution of document change using Arena PLM..


This role implements and maintains document change activities ensuring products and processes are designed with adherence to the Quality Management System.


  • Process document changes involving quality management system documents belonging to Align sites around the globe.
  • Interphase with technical teams, projects or departments in a timely, accurate and efficient manner.
  • Maintain documentation system to ensure full compliance with Medical Device Regulations.
  • Manage changes to multiple documents with a change order so they are reviewed, approved, and made effective as a synchronized group, when applicable.
  • Facilitate the document approval process to change current content with change requests.
  • Support adequate documentation of reason for change.
  • Maintain default routings for different categories of changes.
  • Support the creation/review and maintenance of document approval matrixes.
  • Manage/process changes to the Arena 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.

In this role, you'll need

Typically:

  • 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.
  • Arena PLM experience is a plus.

Sound like a good fit?
Great Click the "Apply" link to let us know you are interested.

Not the right fit? Don't worry, Align is quickly growing so we are creating more opportunities to expand our Align family.

Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.


About Align
Align Technology is a publicly traded medical device company that is

transforming smiles and changing lives. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world's largest manufacturer of custom 3D-printed materials.

By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries.

Great people, innovative technologies, and meaningful work - these are just some of the things employees say make Align Technology a great place to work.

We respect your privacy. Please review our

Applicant Privacy Policies
***for additional information.
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