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
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
Project Manager - Capital Projects
Cork
Senior Quality Engineer
Dublin
Program Manager
Cork
Associate Director Clinical Regulatory S
Cork
Senior Electrical Engineer
Galway
R&D Director
Galway
Quality Validation Engineer
Limerick
Microbiologist
Louth
Medical Device Director
Republic of Ireland
EHS Specialist
Carlow
Project Engineer
Tipperary
Senior Quality Assurance Associate (REMO
Dublin
Batch Record Reviewer
Cork
Qualified Person
Limerick
Project Manager
Limerick
Senior Associate Quality Control NPI
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Validation Specialist - 50/50 remote
Carlow
Senior Regulatory Affairs Specialist
Athlone
Bioprocess Material Associate - Shift
Dublin
Injection Moulding Engineer
Athlone
Associate Global Trade Ops
Dublin
Aseptic Process Lead
Carlow
R&D Lifecycle Manager
Connaught
Quality Control Technician
Carlow
Validation Engineer
Athlone
Compliance Specialist
Carlow
Senior R&D Engineer-New Product Deve
Westmeath
Engineering Projects Lead
Carlow
Manufacturing Technician
Clare
R&D Manager
Galway
Project Manager - Capital Projects
Meath
Senior Associate Quality Control NPI
Dublin
Principal Process Development Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Mechanical Engineer
Dublin
Facilities Engineer
Carlow
R&D Director
Galway
Process Engineer
Cork
Technical Life Cycle & Engineering M
Galway
R&D Engineer
Galway
Electrical and Instrumentation Turnover
Carlow
Quality Specialist
Tipperary
Quality Systems Manager
Dublin
Process Support Specialist
Carlow
Senior Equipment Design Engineer
Dublin
Senior Manufacturing Engineer
Cork
R&D Manager
Connaught
Cleaning Validation Specialist
Cork
Biostatistician
Dublin City Centre
Technical Sales Manager (Chemistry)
Westmeath
Microbiology Manager
Dublin
Project Engineer
Republic of Ireland
Business Systems Director
Louth
Senior Electronic Engineer
Dublin
Quality Engineer
Athlone
Senior Maintenance Technician
Carlow
Senior Research and Development Engineer
Galway
R&D Manager
Galway
R&D Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
Principal Software Engineer
Athlone
Manufacturing Process Specialist
Cork
QA Manager
Canada
Senior Manufacturing Manager (hybrid)
Dublin
Principal Preclinical Scientist
Galway
Chemical Engineer
Tipperary
Injection Molding Engineer
North Leinster
QC Micro Analyst (Shift)
Cork
Senior Project Manager - Electrical
Dublin
Technical Life Cycle & Engineering M
Galway
Lead Project Engineer
Carlow
Senior Quality Engineer
Dublin
QC Chemistry Analyst (Shift)
Carlow
Senior Validation Engineer
Limerick
Senior Technical Transfer Engineer
Cork
Injection Moulding Engineer
Leitrim
R&D Senior Program Manager
Galway
Senior Design Assurance Engineer
Galway
Suite Team Delivery Lead
Tipperary
Procurement Category Manager
Kildare
QA Lead DS/DP Manufacturing
Louth
Validation Specialist
Cork
Lead Maintenance Reliability Engineer
Westmeath
QC Separation Analyst
Cork
Biostatistician
Dublin City Centre
Senior Recruitment Consultant
Republic of Ireland
Warehouse Operations Specialist
Louth
Senior Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior Electronics Engineer
Dublin
Biomedical Engineer
Dublin
R&D Engineer
Dublin
Cleaning Validation Specialist
Cork
Downstream Manufacturing Engineer
Dublin
Process Simulation Technical Engineer
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Medical Science Liaison (MSL)
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
QA Manager
Canada
Manufacturing Engineer
Cork
C&Q Lead
Tipperary
Senior Quality Engineer
Leitrim
Sales/Customer Service Administrator
Clonmel
Staff R&D Engineer- Customer Focus
Dublin
Maintenance Planner
Westmeath
Senior Recruitment Consultant
Republic of Ireland
Operational Excellence Specialist
Meath
Quality Manager
Dublin
Associate Director Clinical Development
Cork
Product Development Engineer
Galway
Senior Design Engineer
Dublin
Electronic Design Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Management System Specialist
Cork
Project Manager - R&D
Galway
Recruitment Consultant
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Scientific Assistant – Quality and Pro
France
R&D Manager
Galway
Quality Technician
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Systems Specialist
Galway
Senior Operations Engineer
Galway
Principal R&D Engineer
Galway
Quality Engineer
Athlone
Senior Project Equipment Engineer
Dublin
Senior Project Manager - Process Develop
Cork
Account Manager UK and Ireland
Republic of Ireland
Qualified Person
Limerick
Senior Associate Scientist (Shift)
Dublin
R&D Director
Galway
Senior Design Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior Director Global Regulatory Lead E
Cork
Process Development Engineer
Galway
Cleaning Validation Specialist
Cork
Senior Associate Quality Control
Dublin South
Manufacturing Project Engineer
Sligo
Senior Equipment Engineer
Dublin
Manager R&D
Connaught
Technical Transfer Specialist
Dublin
R&D Director
Galway
Maintenance Reliability Engineer
Cork
R&D Project Manager
Galway
Validation Engineer
Cork
Senior Project Engineer - Utilities
Dublin
Principal Quality Engineer
Galway
Manufacturing Technician
Clare
QA Engineer
Leitrim
Technical Specialist - Analytical &
Cork
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Process Engineer
Limerick
Senior Validation Engineer
Limerick
Principal Scientist Global Regulatory Af
Cork
Senior Quality Engineer
Leitrim
R&D Engineer
Clare
Senior Design Engineer
Dublin
Associate QA Specialist (Shift)
Carlow
Senior Project Engineer
Cavan
Clean Utilities Engineer
Carlow
Senior HVAC Engineer
Dublin
Senior Design Quality Engineer
Dublin
Sr. Associate - Quality for Computer Sys
Limerick
Head of R&D
Galway
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Senior Equipment Design Engineer
Dublin
CQV Lead
Tipperary
Project Engineer
Limerick
Quality Operations Specialist
Louth
R&D Manager
Connaught
Associate Quality Specialist
Cork
Recruitment Consultant
Wexford
Biomedical Engineer
Dublin
Upstream Manufacturing Process Specialis
Cork
Strategic Automation Lead
Waterford
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs Specialist
Dublin
Senior Equipment Design Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Supply Chain Process Lead
Louth
Senior Recruitment Consultant
Cork
R&D Engineer
Dublin
R&D Manager
Connaught
Senior R&D Project Manager
Galway
Responsible Person (RP)
Republic of Ireland
Technical Transfer Lead
Dublin
QC Laboratory Technician
Carlow
Senior Polymer Development Engineer
Galway
Project Engineer
Roscommon
Senior R&D Engineer
Dublin
Project Manager - R&D
Galway
Global Labelling Technical Regulatory Af
Cork
CMC Regulatory Senior Scientist
Cork
Senior Operations Engineer
Galway
Product Development Engineer
Galway
R&D Engineer
Galway
Aseptic Process Owner Lead
Dublin
Technical Marketing Manager
Wexford
Principal R&D Engineer
Dublin
Senior R&D Engineer
Dublin
QA Operations Specialist
Greece
Specialist Operations Engineer
Tipperary
Injection Moulding Engineer
Athlone
Quality Engineer
Wexford
Lead Maintenance Reliability Engineer
Westmeath
R&D Manager
Connaught
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
QC Bioanalytical Analyst
Dublin
Process Engineer (NPI)
Carlow
Cleaning Validation Specialist
Carlow
Packaging Engineer
Dublin
CQV Engineer (CIP Start Up)
Denmark
Quality Technician
Dublin
Quality Control Specialist (hybrid)
Carlow
R&D Manager
Galway
R&D Engineer
Clare
Senior Manufacting Engineer
Republic of Ireland
E&I Turnover Engineer
Carlow
Senior E&I Maintenance Technician
Carlow
Manufacturing Technician
Clare
Project Enginer
Dublin South
Product Lead
Dublin
Senior Operations Engineer
Galway
CEP Revisions Team leader B5
France
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 Engineer


Reference:JCAO1101 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Senior Quality Engineer

Senior Quality Engineer

Our client a medical device startup company is seeking a Senior Quality Engineer to join their team. Reporting to the Senior Quality Manager the Senior Quality Engineer will work across all stages of development, manufacture, and commercialisation. The candidate will support the Senior Quality Manager with maintaining the Quality Management System. The candidate will also work with R&D, manufacturing and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements. Candidates should have a hands-on approach to projects with a motivated attitude and strong work ethic. An ability to work in a flexible and small entrepreneurial environment is essential.

Role/Responsibilities:

  • Provide quality support during in house manufacture and lot release
  • Development of quality plans, programs and procedures for commercialisation
  • Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
  • Ensure that performance and product quality conforms to company, customer and regulatory requirements.
  • Review, analyse and report on quality discrepancies related to product design and manufacture
  • Liaise and support OEM contractors/vendors during the manufacture of components
  • Support during regulatory agency audits including FDA and Notified Body and aid in the preparation of non-conformity responses, as necessary.
Skills/Experience:
  • Bachelor’s degree in a relevant Engineering or Science field
  • 5 Years’ experience in medical device industry or equivalent higher-level postgraduate study (masters or PhD)
  • Project planning, communication and writing skills
  • Sound understanding of engineering fundamentals
  • Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) essential
  • Cleanroom and sterilisation experience preferred
  • Process validation experience preferred
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322