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Contact Info
Jannet Diana
Life Science

+353 01 507 9255
jannet.diana@lifescience.ie
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Details

Quality, Compliance and Regulatory Affairs Coordinator


Reference:AWPX-834277 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed


Quality, Compliance and Regulatory Affairs Coordinator

Our client, one of the leading medical device distributors across Ireland and U.K are recruiting for QCRA Coordinator who will reporting to the QCRA Manager will the Quality, Compliance and Regulatory Affairs requirements. The successful candidate will manage the ongoing maintenance of our compliance requirements ensuring we meet and exceed our contractual and regulatory obligations, providing best practice in QMS.

The Position

·Support the Quality Manager in relation to the maintenance of our ISO Quality Management System
·Assist in carrying out of Internal Audits to ISO 9001:2015 standard
·Issue and Track non-conformances and CAPAs
·Document Control – version control for SOPs, index register, go live and communication
·Monthly checks for quarantine, calibration and temperature monitoring
·Recording and monitoring of classification of products and identification of any registration or licensing requirements through our Vendor Approval Process
·Management of Quality page and updates to all employees
·Administration of training completion in conjunction with Human Resources
·Processing of requests for Educational Support
·Manage requests for JCI information from customers and liaise with relevant internal departments
·Follow the product complaint reporting process from reporting to close out, liaising with the product manufacturer and internal stakeholders
·Preparation of Monthly reporting of open complaints to QCRA Senior Management, driving complaints to closure with responsible parties
·Follow Field Action process from receipt of Field Action from the manufacturer through to close out with patient safety as our number one priority.
·Responsible for the introduction of new /amended SOPs into QMS working closely with the Projects Department

The Person

·Third level qualification required in Quality, Science, or Business
·2-3 years Administrative experience essential
·Strong communication, interpersonal and prioritising skills
·Good time management
·Keen attention to detail
·Good planning & organizing skills
·A good work ethic with a positive, can do attitude and approach to work
·Ability to work on their own initiative and equally as part of a team
·Full Clean Driving License required
·Strives for Continuous Improvement



If you would like further Information you can contact the recruiter directly:



Jannet Diana | Tel: +353 (0) 1 507 9255





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