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
Clinical Research Manager
Cork
Quality Technician
Dublin
Engineering Support Specialist
Louth
Senior R&D Engineer
Clare
Lead Maintenance Reliability Engineer
Westmeath
Maintenance & Reliability Technician
Limerick
Senior Project Engineer
Cavan
Quality Specialist
Tipperary
Principal R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Dublin
Staff Systems Engineer
Limerick
Senior Manufacting Engineer
Republic of Ireland
Principal R&D Engineer
Dublin
Senior Design Engineer
Dublin
Regulatory Affairs Maanger
Galway
R&D Engineer
Galway
Manufacturing Technician
Galway
Process Engineer
Roscommon
Senior Equipment Design Engineer
Dublin
R&D Director
Galway
Advanced Technologies Manager
Galway
Responsible Person (RP)
Republic of Ireland
Manufacturing Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Senior Regulatory Affairs Specialist
Clare
Embedded Software Engineer
Dublin
Principal Device Engineer
Dublin
Senior Quality Systems Engineer
Galway
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Associate Analytical Scientist
Meath
Senior Quality Assurance Specialist (Shi
Dublin
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Senior Maintenance Technician
Kilkenny
Principal R&D Engineer
Galway
E&I Turnover Engineer
Carlow
R&D Senior Program Manager
Galway
R&D Engineer
Galway
Documentation Specialist
Louth
R&D Manager
Connaught
Learning Systems Lead
Limerick
Manufacturing Technician
Clare
QA Manager
Canada
Senior R&D Engineer
Clare
Clinical Research Associate
Cork
Project Manager - R&D
Galway
Facilities Engineer
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
R&D Technician
Galway
Maintenance Technician
Kilkenny
Principal R&D Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
Manufacturing Engineer
Cork
Principal R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Quality Assurance Team Lead
Cork
R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Learning & Performance Training Asso
Dublin
Territory Manager (Woundcare)
Cork
Quality Engineer
Galway
Maintenance CMMS Engineer
Tipperary
Senior QA CSQ/CQV Specialist
Republic of Ireland
Quality Engineer
Galway
R&D Engineer
Clare
Project Manager - R&D
Galway
Site Microbiologist
Republic of Ireland
Validation Engineer
Athlone
Senior Engineering Manager
Limerick
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Materials Controller (Biopharma - Limeri
Limerick
Strategic Automation Lead
Waterford
Reliability Engineering Consultant - Rem
Republic of Ireland
CTO
Galway
Warehouse Operator
Meath
Project Engineer
Clare
Validation & Verification Engineer
Dublin
Quality Manager - NPI
Dublin
Regulatory Affairs Associate
Cork
Senior Design Engineer
Dublin
Quality Assurance Senior Specialist
Louth
Product Development Manager
Galway
Manufacturing Technician
Clare
Maintenance & Reliability Technician
Limerick
Senior Process Engineer
Carlow
Injection Moulding Engineer
Athlone
Principal Design and Development Enginee
Galway
Senior Associate Quality Control
Dublin
Senior Operations Engineer
Galway
Project Manager Design Assurance
Galway
R&D Engineer
Galway
Senior Maintenance Technician
Roscommon
Lead Chemistry Analyst
Cork
Manufacturing Project Engineer
Sligo
Injection Moulding Engineer
Leitrim
Quality Engineer
Galway
Mechanical Technician
Carlow
Senior Equipment Design Engineer
Dublin
Quality Assurance Specialist (Logistics)
Dublin
R&D Engineer
Galway
Research & Develpment Manager
Galway
Principal Quality Engineer
Galway
Operational Excellence Specialist
Cork
Senior R&D Engineer
Galway
Senior Process Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Assurance Specialist (hyb
Dublin
Design Assurance Engineer
Clare
Principal Research and Development Engin
Galway
Senior Quality Engineer
Dublin
Sr R&D Manager
Galway
Advanced Technologies R&D Manager
Clare
Senior Maintenance Technician
Kilkenny
Injection Molding Engineer
North Leinster
Documentation Specialist
Louth
Senior Regulatory Specialist
Cork
Senior R&D Engineer - Sustaining
Galway
Change Control SME
Cork
Senior Manufacturing Engineer
Galway
Manufacturing Technician
Clare
Process Engineer
Dublin
Principal R&D Engineer
Galway
Senior Technical Transfer Specialist
Cork
DeltaV Lead Automation Engineer
Tipperary
Project Engineer
Louth
Design Assurance Program Manager
Galway
Senior Electronics Engineer
Dublin
Senior R&D Engineer
Galway
Manufacturing Technician
Galway
Maintenance Manufacturing Technician
Kilkenny
R&D Manager
Connaught
R&D Technician II
Galway
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Senior Validation Engineer
Louth
Senior R&D Engineer
Galway
Project Manager
Kildare
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Director Engineering & Supply Chain
Galway
Quality Systems Manager
Dublin
Senior R&D Engineer
Dublin
Engineering Shift Technician
Dublin
Senior R&D Engineer
Galway
Technical Marketing Manager
Wexford
Electronic Engineer
Dublin
Product Development Engineer II
Athlone
Manufacturing Project Engineer
Mayo
R&D Manager
Athlone
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Program Manager
Dublin
Senior Recruitment Consultant
Republic of Ireland
(Senior) Manufacturing Engineers - Globa
Limerick
Senior R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Senior Electronic Engineer
Dublin
Quality Specialist
Clare
Production Operator
Carlow
Project Manager
Louth
Project Manager (hybrid)
Dublin
Senior Quality Systems Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
R&D Director
Galway
Manufacturing Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Manager
Athlone
Design Assurance Program Manager
Galway
R&D Director
Galway
Process Chemist
Limerick
R&D Manager
Connaught
R&D Manager
Galway
Senior Associate Quality Control (Shift)
Dublin
R&D Engineer
Galway
Project Engineer
Limerick
Quality Technician
Dublin
R&D Manager
Galway
Injection Moulding Engineer
Athlone
Manufacturing Engineer
Cork
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Quality Manager
Galway
Utilities Engineer
Dublin
Senior Process Engineer
Longford
Senior Maintenance Technician
Kilkenny
Director of Regulatory Affairs
Galway
Senior Equipment Engineer
Dublin
Senior Research & Development Engine
Limerick
Quality Manager
Galway
R&D Technician II
Galway
Senior Electronics Engineer
Limerick
Principal R&D Engineer
Dublin
R&D Director
Galway
R&D Engineer
Galway
QA Engineer
Leitrim
Senior cGxP Laboratory Technician
Dublin
R&D Manager
Connaught
R&D Manager
Galway
Senior R&D Engineer
Galway
Documentation Specialist
Louth
Regulatory Affairs Associate
Cork
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Staff R&D Engineer
Limerick
R&D Project Manager
Galway
Senior Quality Engineer
Leitrim
Injection Molding Engineer
North Leinster
Quality Technical Services Manager - 12
Dublin
Senior Regulatory Specialist
Cork
Principal R&D Engineer
Galway
Sourcing Specialist
Tipperary
Principal Software Engineer
Athlone
Product Specialist (Endoscopy)
Dublin
R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
R&D Engineer
Galway
Quality Specialist
Clare
Purchasing & Planning Manager
Wexford
R&D Manager
Galway
Electronic Engineer
Dublin
MS&T Scientist - AKTA systems
Meath
Quality Specialist
Clare
CTO
Dublin
Electrical Technician
Limerick
Injection Molding Engineer
North Leinster
Project Manager
Kildare
R&D Manager
Dublin
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]