Document Control Specialist

Document Control Specialist
Empresa:

Align Technology, Inc


Lugar:

Madrid


Área:

Otros

Document Control Specialist

Detalles de la oferta

Description

The Document Control Specialist – Level 1 supports the creation, revision and control of Quality documents and records needed to ensure that the development, manufacture and distribution of medical device products is in compliance with Align policies, US FDA regulations, ISO 13485 and all other applicable requirements of other global regulatory bodies.

The Document Control Specialist must work independently, with minimal or no supervision. In addition, this individual must have excellent organizational skills and knowledge of electronic documentation systems. The Document Control Specialist must be able to multi-task and work well in a fast paced professional environment, be detail oriented, and have the computer skill level to create master documents i.e. templates, forms, logs etc. This individual must possess a high level of computer literacy and knowledge of various software programs.
ESSNTIAL DUTIES AND RESPONSIBILITIES:
Implement document control processes and ensure global consistency or alignment.
Ensure document control procedures comply with local or country specific regulations as well as internal policies and procedures.
Be responsible for maintaining the change control process in Arena, including the review of change control documents and deliverables.
Coordinate with other functional areas to ensure accurate, complete and efficient change control processing.
Review and assist in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations.
Review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval.
Maintain applicable forms and templates.
Track, follow-up and implement change control records.
Interface at all levels with all departments to service their requirements in an efficient professional manner.
Create and maintain all hard and soft copy master files for active and archival documentation.
Assist with all department projects as required.
Participate in proactive team efforts to achieve departmental and company goals.
QUALIFICATIONS:
Strong oral and written communication skills.
Strong computer skills.
Ability to communicate and interact with customers of various education levels and cultural diversity.
Excellent organizational skills.
Demonstrated ability to manage time effectively, prioritize multiple requests, and meet deadlines.
Ability to efficiently create, edit, and format Word, PowerPoint, and Excel documents
Proficient in English language
EDUCATION and/or EXPERIENCE:
1-4 years experience in an electronic documentation environment.
Familiar with ISO Standards.
Excellent advanced Computer skills in Microsoft Word and good skills in Excel, Power Point required.
Working knowledge of other specialized programs such as Visio, Illustrator, Photoshop or Acrobat desired, not required.
Knowledge of Arena or Agile PLM systems a plus.
We look forward to working with you! Together we can help patients smile with confidence for years to come.

Ciudad: las rozas


Fuente: Neuvoo_Ppc


Área:

  • Otros / Otros

Requisitos

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