Role:
Senior Quality Systems Engineer
Location:
Parkmore, Galway (Hybrid working)
Benefits:
Top salary, hybrid working, bonus, pension and healthcare
Company:
My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore.
They have developed an innovative new technology to improve the performance of Vascular stents.
Role:
Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the 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 Veryan Quality Systems are compliant with, the Medical Device Directive *****/EEC, Medical Device Directive *******/EC, Medical Device Regulation ********, FDA Quality System Regulations 21 CFR § 820 & 803, ISO *****, ISO ***** and Japanese Ministerial Ordinance # 169.
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.
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 ISO*****, ISO*****, Medical Device Regulation ******** 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 *********** or email ******
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