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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Quality Systems Engineer


Reference:TG - SQSE Location: Galway
Galway City
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Engineer, QA Manager, QA Specialist, QA Validation Specialist, Quality Engineer, Quality Specialist, Quality Systems Engineer, Quality Systems Lead

Role: Senior Quality Systems Engineer
Location:ATU Ihub - Galway
Benefits: Top salary, hybrid working, bonus, pension and Shares



Company:
Brand new Medical Device start up with exciting new adventure.


Role:
Senior Quality Systems Engineer you will play a key role in the Set up, implementation and maintenance of the company’s Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway.



Responsibilities:

  • Ensure the companies Quality Systems are compliant with, the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971.
  • Maintenance and continuous improvement of the quality management systems.
  • Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines.
  • Review & approval of Non-conformance, CAPA and Complaint investigation reports.
  • Act as Coordinator for the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required. Track audit actions from initiation to closure.
  • Coordinate activities in the preparation and management of audits by regulatory bodies.
  • Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.



Education & Training

  • Educated at a minimum to a Diploma Level in an Engineering, Science, or Quality Assurance discipline.
  • Training/Qualification in Quality Systems, Complaints and CAPA is highly desirable.

  • A minimum of five years’ relevent experience in the medical device industry.
  • Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required.
  • Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable.



To apply for more info call me on 087 0612325 or email [email protected]