I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Thomas Gallagher
Life Science

+353870612325
[email protected]
Connect with me on
Hot Science Jobs
Quality Engineer
Athlone
R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Senior R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Project Manager
Kildare
Senior Mechanical Engineer
Dublin
Quality Assurance Associate
Cork
Product Development Engineer
Dublin
Territory Sales Specialist (Life Science
Belfast City
Project Manager - R&D
Galway
Electronic Engineer
Dublin
R&D Director
Galway
Senior R&D Engineer
Galway
Quality Manager - Medical Devices
Limerick City
R&D Manager
Galway
Reg Affairs Specialist
Connaught
Quality Engineer
Galway
Regulatory Affairs Manager - Senior
Galway
Senior Regulatory Affairs
Galway
Product Development Engineer II
Athlone
Senior Design Assurance Engineer
Galway
Senior Engineering Manager
Limerick
Project Manager - New Product Introducti
Dublin
R&D Engineer
Galway
R&D Scientist (Microbiology)
Wexford
QA Manager
Canada
Senior QA Associate (24/7 Shift)
Dublin
Electronic Engineer
Dublin
Product Development Engineer
Dublin
Senior QC Associate (Bioassay)
Dublin
EHS Officer
Dublin
R&D Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Galway
Responsible Person (RP)
Republic of Ireland
QA Engineer
Leitrim
Principal Instrumentation & Calibrat
Limerick
Project Engineer
Cork
Application Software Engineer
Galway
Injection Moulding Engineer
Athlone
Manufacturing Technician
Clare
Principal Process Equipment Engineer
Dublin South
R&D Manager
Connaught
Technical Life Cycle & Engineering M
Galway
Senior Process Engineer
Longford
Injection Molding Engineer
North Leinster
R&D Director
Galway
Quality Manager
Galway
Electrical Condition Monitoring Technici
Limerick
R&D Manager
Athlone
Injection Moulding Engineer
Athlone
Injection Moulding Engineer
Leitrim
Senior Quality Control Associate
Dublin South
Director Engineering & Supply Chain
Galway
Quality Specialist
Clare
Senior Product Development Engineer
Galway
R&D Engineer
Clare
CTO
Dublin
Health & Safety Specialist
Dublin
Design Assurance Engineer
Galway
Principal R&D Engineer
Galway
Senior Research and Development Engineer
Galway
Documentation Specialist
Louth
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Clare
Scientific Officer Training Development
Dublin
R&D Director
Galway
Strategic Automation Lead
Waterford
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Calibration Technician
Republic of Ireland
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Product Development Technician II
Galway
Senior Maintenance Technician
Kilkenny
Senior QC Associate
Dublin
Senior Regulatory Specialist
Cork
Technical Marketing Manager
Wexford
Maintenance & Reliability Technician
Limerick
Senior Manufacting Engineer
Republic of Ireland
Project Manager Design Assurance
Galway
R&D Manager
Connaught
Senior Product Development Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
Senior R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Injection Molding Engineer
North Leinster
Quality Technician
Dublin
Senior R&D Engineer
Galway
Project Manager (hybrid)
Dublin
R&D Engineer
Galway
Project Manager
Kildare
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
R&D Manager
Galway
Quality Assurance Specialist (hybrid)
Dublin
Senior R&D Manager
Athlone
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Engineering Business Manager
Dublin
Electronic Engineer
Dublin
R&D Engineer
Galway
Senior Project Engineer - R&D
Galway
R&D Technician II
Galway
Validation Engineer
Athlone
Senior QC Associate
Dublin
Quality Engineer
Galway
Injection Molding Engineer
North Leinster
Senior Maintenance Technician
Kilkenny
Staff R&D Engineer
Limerick
Electronic Engineer
Dublin
Principal R&D Engineer
Galway
Product Development Engineer
Galway
Warehouse Operator
Meath
Senior Quality Engineer
Dublin
Quality Specialist
Tipperary
Principal Engineer
Dublin
Quality Assurance Specialist (Logistics)
Dublin
Sales/Customer Service Administrator
Clonmel
Production Operator
Meath
Operations Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer-New Product Deve
Westmeath
R&D Manager
Connaught
Senior Operations Engineer
Galway
Senior Process Development Engineer
Galway
R&D Engineer
Galway
R&D Technician II
Galway
Continuous Improvement Coach
Limerick
Advanced Technologies Manager
Galway
R&D Engineer
Galway
Project Manager - R&D
Galway
Senior Quality Engineer
Dublin
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
EHS Officer
Dublin
Principal R&D Engineer
Galway
Senior Manufacturing Engineer
Galway
Senior Quality Engineer
Dublin
QC Bioanalytical Sciences - Senior Assoc
Dublin
Project Manager - R&D
Galway
Project Manager
Galway
Quality Manager
Galway
R&D Engineer
Galway
CTO
Galway
Advanced Technologies R&D Manager
Clare
R&D Engineer
Galway
Senior Quality Engineer
Galway
Electronic Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Product Development Engineer
Dublin
Senior Regulatory Affairs Specialist
Clare
Senior Electronic Engineer
Dublin
Quality Technician
Dublin
Regulatory Affairs Associate
Cork
Quality Engineer
Galway
Senior Product Development Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Product Development Engineer II
Athlone
Process Chemist
Limerick
R&D Manager
Athlone
R&D Engineer
Dublin
Electronic Engineer
Dublin
Principal Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior Project Engineer
Cavan
Senior Principal Design and Development
Galway
Senior Equipment Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Senior Program Manager
Galway
R&D Engineer
Galway
Principal Device Engineer
Dublin
Senior R&D Engineer
Dublin
Project Engineer
Roscommon
Production Manager
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Galway
Senior R&D Engineer
Galway
Warehouse Operator
Meath
Pharmacovigilance Manager (Remote)
Republic of Ireland
R&D Manager
Dublin
Quality Specialist (hybrid)
Tipperary
Customer Services Manager (Pharmaceutica
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Business Development Representative-Cali
Republic of Ireland
Senior R&D Engineer
Clare
Mechanical Technician
Carlow
Engineering Shift Technician
Dublin
Director of R&D
Limerick
R&D Director
Galway
Sr Electrical Engineer
Galway
Senior Regulatory Affairs Specialist
Westmeath
Quality Engineer
Athlone
R&D Manager
Galway
Principal Design and Development Enginee
Galway
Senior Project Engineer
Cavan
Design Assurance Program Manager
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Senior Quality Systems Engineer


Reference:TG - SQSE Location: Galway
Galway City
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: 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: 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 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 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.
  • 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.
  • Prepare and present data to management on quality system performance, including Monthly Quality Reports.
  • Generate Quality Systems data as required for Post Market Surveillance purposes.
  • Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
  • Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required.


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]