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
Injection Molding Engineer
North Leinster
Product Development Manager
Galway
Senior R&D Engineer
Galway
Senior QC Microbiology
Dublin
Quality Engineer
Galway
Quality Engineer
Galway
R&D Engineer
Dublin
Senior Project Manager - Process Develop
Cork
Quality Engineer
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Quality Engineer
Athlone
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Equipment Engineer
Dublin
Quality Systems Specialist
Tipperary
Senior Quality Engineer
Dublin
Senior R&D Engineer
Dublin
Engineering Shift Technician
Dublin
Quality Manager - Medical Devices
Limerick City
Associate Director - Global Core Labelin
Cork
Director of Regulatory Affairs
Galway
NPI Process Engineer
Carlow
Manufacturing Technician
Clare
Principal R&D Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Research and Development Engineer
Galway
R&D Engineer
Galway
Design Assurance Engineer
Clare
R&D Technician II
Galway
Process Support Specialist
Carlow
Embedded Software Engineer
Dublin
Project Engineer - Senior
Cavan
Production Operator
Dublin
Quality Engineer
Galway
Software Design Assurance Engineer
Dublin
Design Assurance Program Manager
Galway
Safety & Environmental Specialist
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Maintenance Reliability Engineer
Cork
Principal Software Engineer
Athlone
Senior R&D Manager - Lifecycle Manag
Galway
Quality Systems Specialist
Tipperary
R&D Manager
Connaught
Senior Associate QC
Dublin
R&D Engineer
Galway
Senior Regulatory Specialist
Cork
R&D Director
Galway
EHS Systems Specialist
Dublin
QA Manager
Canada
Quality Specialist
Clare
Quality Specialist
Dublin
Cleaning Validation Specialist
Cork
R&D Manager
Connaught
Sales/Customer Service Administrator
Clonmel
R&D Manager
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Design Assurance Engineer
Galway
Process Engineer
Cork
Quality Specialist & Deputy RP
Limerick
R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Validation & Verification Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
Investigation Lead
Dublin
Senior Electronic Engineer
Dublin
Project/Process Engineer - Purification
Cork
R&D Director
Galway
R&D Manager
Galway
Senior R&D Engineer
Galway
Project Manager
Galway
Head of R&D
Galway
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
Quality Systems Specialist
Tipperary
Quality Assurance Engineer
Longford
MS&T Associate Director
Dublin
Project Engineer
Clare
Quality Engineer
Galway
VP of Operations
Dublin
R&D Engineer
Clare
Responsible Person (RP)
Republic of Ireland
Senior R&D Project Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
Principal Engineer
Dublin
Change Control SME
Cork
R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Quality Engineer
Galway
Product Development Engineer
Dublin
Project Manager
Louth
Senior Quality Systems Engineer
Galway
Operations Excellence Lead
Louth
Senior Technical Transfer Specialist
Cork
Reg Affairs Specialist
Connaught
Facilities Engineer
Carlow
R&D Director
Galway
Electronic Engineer
Dublin
Senior Quality Engineer
Galway
R&D Manager
Galway
Injection Molding Engineer
North Leinster
Microbiologist
Cork
Cleaning Validation Specialist
Cork
QC Separation Analyst
Cork
Senior R&D Engineer
Galway
Upstream Manufacturing Process Specialis
Cork
Project Engineer
Limerick
Regulatory Affairs Associate
Cork
Quality Manager
Galway
Sourcing Specialist
Tipperary
R&D Senior Program Manager
Galway
Senior R&D Engineer
Galway
R&D Manager
Athlone
Senior Recruitment Consultant
Dublin
R&D Manager
Connaught
Senior Technical Transfer Engineer - Hyb
Carlow
R&D Engineer
Galway
Medical Writer
Cork
Project Manager Design Assurance
Galway
R&D Director
Galway
Design Quality Assurance Engineer
Galway
Senior Human Factors Engineer
Dublin
R&D Program Manager
Dublin
R&D Engineer
Galway
Senior Quality Systems Engineer
Galway
R&D Manager
Galway
Quality Control Technician
Carlow
Biostatistician
Dublin City Centre
R&D Manager
Galway
Electronic Engineer
Dublin
Senior QA Associate (Shift)
Dublin
Maintenance Technician
Carlow
Technical Transfer Specialist
Cork
Senior Quality Engineer
Leitrim
Quality Engineer
Galway
CTO
Dublin
Senior Regulatory Affairs
Galway
Process Simulation Technical Engineer
Carlow
Senior QC Microbiology (24/7 Shift)
Dublin
R&D Engineer
Galway
Senior Engineering Manager
Limerick
Production Operator
Carlow
Senior Quality Engineer
Dublin
Product Development Engineer
Dublin
EHS Specialist
Meath
QC Systems Specialist
Dublin
R&D Manager
Galway
Principal Engineer - R&D
Galway
Principal/Senior R&D Engineer Cathet
Galway
Operational Excellence Specialist
Cork
Production Operator
Meath
Cleaning Validation Engineer
Carlow
R&D Engineer
Galway
Principal Engineer - R&D
Galway
Supply Chain Senior Associate (hybrid)
Dublin
Product Development Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Quality Operations Manager
Dublin
Senior R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Process Chemist
Limerick
Senior Manufacturing Manager
Dublin
QA Operations Specialist (hybrid)
Meath
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Regulatory Affairs Specialist
Athlone
Process Safety Specialist
Tipperary
Senior R&D Engineer
Dublin
Quality Technician
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Maintenance Reliability Engineer
Tipperary
Production Operator
Dublin
Principal Process Equipment Engineer
Dublin South
Business Development Manager - Leinster
Dublin
Manufacturing Engineer
Galway
Biomedical Engineer
Dublin
Quality Manager
Galway
R&D Engineer
Dublin
Product Development Technician II
Galway
Electronic Engineer
Dublin
Regional Program Coordinator - Global Le
Dublin
R&D Manager
Athlone
Cleaning Validation Specialist
Carlow
Maintenance Technician
Kilkenny
Lead Chemistry Analyst
Cork
CTO
Galway
Senior Associate Quality for Computer S
Limerick
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Quality Systems Manager
Dublin
NPI Process Engineer
Carlow
Cleaning Validation Specialist
Cork
Quality Specialist
Clare
Maintenance Technician
Carlow
Supply Associate QC - Metrics & Anal
Dublin
Engineering Projects Lead
Carlow
Senior Design Assurance Engineer
Galway
Manufacturing Technician
Clare
Senior Validation Engineer
Carlow
Quality Specialist
Tipperary
Biomedical Engineer
Dublin
Scientist (hybrid)
Meath
QA Engineer
Leitrim
QA Manager
Canada
Chief Medical Officer
Dublin
Senior Design Engineer
Dublin
Product Development Engineer
Galway
Senior Procurement Associate
Limerick
R&D Engineer
Galway
MS&T Bioprocess Engineer
Meath
Senior Validation Engineer
Carlow
Senior Validation Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Manufacturing Engineer
Cork
Principal Engineer - R&D
Galway
QA Specialist (REMOTE)
Dublin
Reg Affairs Specialist
Connaught
Manufacturing Biotech Associate 24/7 Shi
Meath
Project Manager - R&D
Galway
Principal Quality Engineer
Galway
Manufacturing Engineer
Galway
Injection Molding Engineer
North Leinster
Reliability Engineer
Tipperary
Principal Heart Valves Engineer
Galway
Manufacturing Engineer
Wexford
Quality Control Technician
Carlow
Principal Preclinical Scientist
Galway
R&D Engineer
Galway
Senior Operations Engineer
Galway
Director of Quality Engineering
Limerick
Project Engineer
Roscommon
Senior Design Engineer
Dublin
R&D Engineer
Galway
Electronic Engineer
Dublin
Project Manager - R&D
Galway
Regulatory Affairs Specialist
Cork
Senior Manufacturing Engineer
Galway
Strategic Automation Lead
Waterford
Validation Specialist - 50/50 remote
Carlow
DeltaV Lead Automation Engineer
Tipperary
Senior R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Project Engineer
Cavan
Graduate Manufacturing Technician
Kilkenny
R&D Manager
Dublin
Senior Electronic Design Engineer
Dublin
Senior Quality Engineer
Dublin
Engineering Business Manager
Dublin
Principal Process Development Engineer
Galway
Change Control Lead
Tipperary
Quality Control Technician
Carlow
Senior Manufacting Engineer
Republic of Ireland
Medical Secretary
Cork
EHS Officer
Dublin
Senior Equipment Design Engineer
Dublin
Territory Sales Specialist (Life Science
Belfast City
Notified Body Product Assessor -Active D
Canada
Senior Project Engineer
Cavan
Lead Maintenance Reliability Engineer
Westmeath
QA Specialist (Shift days)
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 - SQS - Galway Location: Galway
Galway City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer, Quality Systems Engineer, Quality Systems Lead, Quality Systems Specialist

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]