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 Coordinator 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.
Responsibilities
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.
Ensure compliance with local, corporate, and regulatory requirements.
Interact with internal/external customers, auditors, and other professionals.
Accurately maintain all documents controlled by the department utilizing the necessary methods and databases.
Support the maintenance of the External Standards Library, as required.
Distribution, maintenance, and tracking of new/obsolete documents.
Qualifications
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 communication 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 in rough draft format and type/format documents consistently 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.
Benefits
Salary range: €36,000 - €37,000.
Equal Opportunity Employer
Becton, Dickinson, and Company is an Equal Opportunity Employer.
We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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