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QA Specialist Medical Devices

  1. NI & Ireland
  1. Contract
  1. Compliance / Quality Assurance
Date Posted02 Feb 2021

This vacancy has now expired

QA Specialist -Medical Devices – 12-month contract – Dublin

As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking a QA Specialist to become part of a $500 million state of the art bio facility.

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility. 

Essential Duties and Responsibilities for this QA Specialist role include, but are not limited to, the following:
  • As the QA Specialist you will be responsible for reviewing and approval of batch release for combination products.
  • The QA Specialist will support the development of the Quality Management System as it pertains to Medical Devices and Combination Products to achieve the ISO 13485 standard and compliance with 21 CFR Part 4 and the Medical Device regulation 2017/745.
  • You will be responsible for the coordination and documentation of the Change Control Review Board for Medical Device Changes.
  • The QA Specialist will be responsible for documenting and periodic review of Supplier Quality Requirements and Supplier Quality Agreements.
Desirable Experience:
  • As the QA Specialist you will be qualified to degree level and gained a minimum of 4 years’ experience working as a QA Specialist within Medical Devices or Combination Products.
  • The QA Specialist will have strong knowledge of the Regulatory and Compliance requirements of design control for Medical Devices or Combination Products.
  • You will have strong experience with Risk Management Standards for Medical Devices ISO 14971 2019

If you feel you match these requirements and would like to know more about this fantastic opportunity then please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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