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
Thomas Gallagher
Life Science

+353870612325
[email protected]
Connect with me on
Senior Recruitment Consultant
Republic of Ireland
R&D Director
Galway
Graduate Laboratory Technician
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Project Enginer
Dublin South
Process Engineer
Limerick
R&D Director
Galway
Head of R&D
Galway
Quality Specialist
Tipperary
Procurement Lead
Limerick
Recruitment Consultant
Republic of Ireland
Medical Device Director
Republic of Ireland
R&D Manager
Galway
R&D Manager
Galway
Project Manager
Limerick
Project Engineer
Tipperary
Project Engineer
Republic of Ireland
R&D Director
Galway
Chemical Engineer
Tipperary
R&D Engineer
Dublin
Qualified Person
Limerick
Senior Quality Engineer-Remote
Republic of Ireland
R&D Manager
Galway
Senior Manufacting Engineer
Republic of Ireland
R&D Manager
Galway
Project Engineer
Limerick
QC Analyst
Meath
C&Q Lead
Tipperary
CQV Lead
Tipperary
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

Quality Assurance Specialist


Reference:TG - QE - Shannon Location: Clare
Limerick
Limerick City
Republic of Ireland
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Job title: Quality Assurance Specialist
Location: Western Business Park, Shannon, Co. Clare
Benefits: Good salary, Healthcare, pension, opportunity to grow your career with exciting Medical Device company working on projects from concept.


Summary:
The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing including secondary packaging activities and Distribution.



Responsibilities:

  • Aid the team in the development implementation and maintenance of the Quality Management System.
  • Support the operation of the Quality Management System & Documentation control such as:
    • Change Controls, CAPAs and Non conformances, Training, Internal, vendor and third party audits, participate in product and process risk assessments.
    • Perform Internal Audits or Supplier audits.
    • Perform Supplier Qualification & monitoring as requested.
    • Drive continuous improvement initiatives within the QMS.
    • Partake in Customer specific or internal quality projects.
    • Perform QA Verification of activities performed in production.
    • Review and update Quality System documentation (procedures, Reports) as requested.
    • Partake in activities for design & process validation.
    • Take part in Notified Body Audits and Audit preparation as requested. Generate Quality Metric reports as required and assist in any other data compilation as requested.
  • Customer specific tasks:
  • Perform assigned tasks in accordance with specified Procedures.
  • Ensure protection of client confidential information in accordance with Non-Disclosure Agreements.
  • Perform specific duties associated with client services as specified in client contracts/service agreements.
  • Perform all tasks in compliance with company policies and procedures.
  • Support Key Projects and other duties as assigned.


Requirements:
  • Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level).
  • 3+ years’ experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices).
  • Good planning and organizational skills.
  • Good communication (oral and written).
  • Hardworking and highly motivating individual, with good attention to detail.

Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR [email protected]