Document Controller en Cork a Stryker Corporation

Fecha de publicación: 8/7/2019

Resumen de la oferta

Descripción del empleo

Position Summary

Will work within the Quality Systems team, under general supervision, with responsibility to ensure an effective and efficient management and release of documentation, this includes, but is not limited to the following duties:

Your key responsibilities

  • Responsible for all activities related to document routing, distribution and release to assure that the latest effective copies are available as required.
  • Ensure prompt archiving and storage of all Stryker documentation.
  • Timely retrieval of documents and information, as needed to complete investigations and/or reports.
  • Subject Matter Expert for document management procedures, update and revise procedures to improve practices and systems by reflecting the current best practices.
  • Subject Matter Expert (super user) for the Product Life-cycle Management system.
  • Will provide coaching, training, clinics, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes.
  • Contribute to and drive improvement initiatives within the Quality Systems team, participate in multi-functional teams to achieve collaborative results.
  • Effective interface & communication with functional disciplines to ensure efficient and constructive interdepartmental interactions for Documentation aspects.
  • Provide training to cross functional groups on PLM and regulatory requirements related to Documentation control.
  • Periodic/requested participation in product development team
  • Support & comply with GMP/QSR, ISO 13485 & CE-mark requirements.
  • Input to & maintain quality KPIs for trending/management reviews.
  • Assist in issue investigations, provides input to correction & resolution, rework, problem solving, and process improvements.
  • Maintain an organized, clean, safe & health conscious work environment.
  • Assist with company regulatory audit activities, as deemed necessary.

What are we looking for?

  • Third Level Qualification (Diploma in Business Studies or Administration, or equivalent 2 year certification / Berufsausbildung) preferred.
  • Relevant experience in a similar administrative type role in a Regulated Industry, advantageous.
  • High level of PC skills required, must be highly proficient with Microsoft.
  • Have an understanding of archiving systems and methodology and electronic document managing systems.
  • Have an understanding of the following standards ISO 13485 and ISO 9000  and CFR Part 820 Quality System Regulations
  • Must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines with acute attention to detail
  • Is a self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • Be capable of working as part of a multi-disciplined team

Work From Home: No

Travel Percentage: None

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