We are seeking a Doc Control Co‑ordinator for our Enniscorthy facility, where we manufacture angioplasty catheters for coronary and peripheral procedures.
Responsibilities
Develop, coordinate, implement, and revise Quality Management System documentation processes and systems while ensuring compliance with FDA QSR and ISO requirements.
Administer and maintain related systems, including internal/supplier audit schedules, validation, action item trackers, training, and documentation.
Review, process, and coordinate submitted Change Requests.
Set up and print sample labels as needed.
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 and external customers, auditors, and other professionals.
Maintain all documents controlled by the department using required methods and databases.
Support the maintenance of the External Standards Library.
Distribute, maintain, and track new or obsolete documents.
Qualifications
Completed third‑level qualification with 3–4 years of document control experience or prior experience in the medical device industry.
Problem‑solving skills and the ability to apply judgment when dealing with internal and external customers.
Strong prioritisation and organisational skills to manage a busy and changing workload.
Excellent oral and written communication skills and attention to detail.
Strong coordination skills and the ability to follow up on open items through to completion.
Ability to read documents in rough draft format and to 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.
Salary Range: €36,000 – €37,000 per year.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, citizenship status, marital or domestic union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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