Document Control Co-Ordinator

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Job Description

At the Enniscorthy facility, we manufacture mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are looking for a Doc Control Co-Ordinator to join our team on a permanent basis.

You will be responsible for the processing and administration of all controlled documents and standards in the Document Control System and related database systems in accordance with local, corporate and Regulatory requirements.

Main responsibilities will include:

• Develop, coordinate, implement, and revise Quality Management System Documentation related processes and systems while assuring compliance with the FDA QSR and ISO requirements.
• Perform administration and maintenance of systems including but not limited to the following: Internal/Supplier Audit Schedule/Observations; Validation; Action Item Tracker; Training; Documentation, as required.
• Review, process and coordinate submitted Change Requests (CR)
• Set up and print sample labels as required
• Process external customer/supplier documents in accordance with corporate, local procedure and regulatory requirements as required.
• Ensure compliance to local, corporate, and regulatory requirements
• Interact with internal/external customers, auditors, and other professionals.
• Accurately maintain all documents controlled by the department utilising the necessary methods and databases.
• Support the maintenance of the External Standards Library, as required.
• Distribution, maintenance, and tracking of new/obsolete documents.

About you:

• Completed 3rd level qualification with 3-4 years of document control experience, or prior experience within the medical device industry.
• Problem solving and/or application of judgment in dealing with internal/external customers.
• Ability to prioritise and organise a busy and changing workload.
• Excellent oral and written communications skills and attention to detail.
• Strong coordination skills and ability to follow up on open items through to completion.
• Must have the ability to read documents is rough draft format and type/format documents consistent with corporate guidelines.
• Intermediate to advanced knowledge of Microsoft Word, Excel, Access, and the ability to learn and work with various computer programs and databases.

The salary range: €36,000 - €37,000