Our client, a leading multinational in the Medical Devices sector is recruiting a Document Controller to join the Quality Team on their site in Cork.
- Acting as an SME for document management procedures, updating and revising procedures to improve practices and systems in accordance with best practice
- Super user for the Product Life-cycle Management system, providing coaching and support to functions in using and navigation the PLM system and execution of documentation and change processes.
- Responsible for all activities related to document routing, distribution and release
- Assuring the latest effective copies of documents are available as required
- Ensuring efficient archiving and storage of all company documentation
- Prompt retrieval of all documents and information as required to complete reports, investigations, etc.
- Occasional participation in the product development team
- Supporting and complying with GMP/QSR, ISO13485 and CE mark requirements
- Assisting with regulatory audit activities as required
- Contributing to and driving process improvements within the Quality team.
- Contributing to and maintaining quality KPI?s
- Third level degree in Business/Administration or similar relevant area
- Previous experience in a similar role in regulated environment
- An understanding of ISO13485, ISO9000 and CFR Part 820 Quality Systems
- Ability to work as part of a cross-functional team
- Strong IT skills with a high proficiency in Microsoft Office Suite
- Knowledge of archiving systems and methodology
- An understanding of electronic document managing systems
- Excellent organisational and time-management skills
- Ability to multi-task and prioritise effectively in order to meet deadlines
- Strong problem solving skills with an analytical approach to work and attention to detail
For further information on this Document Controller role in Cork please contact Aisling Reardon on 091730022 / email@example.com
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