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
Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Data Architect
Cork City
Project Engineer
Republic of Ireland
Project Enginer
Dublin South
R&D Engineer
Galway
R&D Engineer
Galway
Quality Specialist
Tipperary
Head of R&D
Galway
QA Engineer
Leitrim
Chemical Engineer
Tipperary
Senior Recruitment Consultant
Republic of Ireland
R&D Engineer
Dublin
R&D Director
Galway
R&D Manager
Galway
R&D Director
Galway
Qualified Person
Limerick
Qualified Person
Limerick
R&D Manager
Galway
Project Engineer
Limerick
C&Q Lead
Tipperary
Senior Recruitment Consultant
Republic of Ireland
QA Manager
Canada
R&D Engineer
Galway
R&D Manager
Galway
Senior Manufacting Engineer
Republic of Ireland
R&D Director
Galway
Senior Quality Engineer-Remote
Republic of Ireland
CQV Lead
Tipperary
R&D Engineer
Dublin
Scientific Consultant
Republic of Ireland
Account Manager UK and Ireland
Republic of Ireland
Biostatistician
Dublin City Centre
Recruitment Consultant
Republic of Ireland
Medical Device Director
Republic of Ireland
Project Engineer
Tipperary
Responsible Person (RP)
Republic of Ireland
Process Engineer
Limerick
Biostatistician
Dublin City Centre
Project Manager
Limerick
HPLC QC Consultant - Greece
Republic of Ireland
R&D Manager
Galway
QA Manager
Canada
R&D Engineer
Galway
Product Lead
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 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