Global Document Services Administrator

hace 1 semana

San Francisco, Heredia, Costa Rica Aligntech A tiempo completo

**Join a team that is changing millions of lives.
**

Transforming smiles.
Transforming lives.
Transforming an industry.
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 teams are constantly pushing the boundaries of what's possible.
Ready to join us?
**About this opportunity**

The Administrator, Global Document Services forms 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.
The Administrator, Global Document Services shall:

- Execute the global document change management and control processes for the different company sites around the world
- Perform the appropriate processing of change requests and change orders for quality management system documents
- Support development and configuration of the global document change control software
- Assist in the definition and implementation of standardized metrics and KPIs to facilitate process governance

This role also provides advice and user support across the global business on the use of the global document change management and control software supporting the execution of document change process.
Develops implements and maintains the activities ensuring products and processes are designed with adherence to the Quality Management System.
**In this role, you will**
- Process the 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 current 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 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 **

**Education / Experience**
- 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.
- **
Essential Skills**
- Capable and knowledgeable regarding PLM(Product Lifecycle Management) or eDMS (electronic Document Management configuration and maintenance)
- Receptive to working in a fast-paced, dynamic, constantly changing work environment.
- Ability to role model compliant behavior's in all situations.
- Strong English writing and communication skills.
- Works with appropriate parties to manage and resolve Quality System issues.
Working collaboratively to create, embed and sustain compliance focused outcomes across all global functions.
- Carry out planned work with minimum supervision to contribute to meeting business goals.
- Solution-oriented Approach Maintains a positive and solution-oriented approach to work, providing open and honest feedback within team.
**Desirable Skills**
- Internal Auditor, ISO13485
- Qualified Trainer
- Process Excellence certified (Green Belt / Black belt).
**Sound like a good fit?
**
***
***
**About Align**

Invisalign clear aligners, iTero Intraoral scanners, and OrthoCAD digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.

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