I'm looking for...

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.

Google Chrome
Internet Explorer
Mozilla Firefox

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
Validation Lead
Qualified Person
Quality Engineer
Process Engineer
eClinical Project Coordinator
Republic of Ireland
R&D Engineer
Limerick City
Head of R&D
Project Manager
Project Engineer
Process Engineer
Dublin North
Senior Planner
Senior R&D Engineer
Limerick City
QC Scientist
R&D Manager
Technical Writer
Project Engineer
eClinical Project Manager
Republic of Ireland
R&D Manager
QA Manager
Business Program Lead - Remote
Republic of Ireland
C&Q Engineer
Clinical Research Associate (CRA)
Republic of Ireland
Apply for this job






Salary Expectations:



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]

Senior Design Quality Engineer

Reference:JCAO010121 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Senor Quality Design Engineer

Our client a Medical Device multinational currently seeks a Senior Quality Design Engineer to join their team. The Senior Quality Design Engineer will be responsible for providing on-going design and quality assurance expertise and leadership in an EMEA Centre of Excellence team


  • Provision of on-going regulatory compliance, risk management, design control, quality systems and overall design assurance expertise and leadership to the EMEA Centre of Excellence team on an on-going basis.
  • Provision of regulatory and quality systems leadership to the team as it transitions to Design Ownership (Design Authority).
  • Liaison with corporate, local and EMEA sites quality systems and regulatory affairs personnel to ensure team’s compliance and to drive alignment and harmonization.
  • Monitoring of the release and updates to regulatory & quality standards, regulations and policies, execution of gap analysis, communication of changes to the team and driving compliance.
  • Driving the implementation, maintenance and update of procedures that ensure packaging and labelling design controls are met.
  • Creating and maintaining risk management documentation.
  • Providing independent quality review for design reviews, project design plans, risk management, design validation protocols & reports for both design and development projects.
  • Support the team in their design & development activities, carried out on behalf of other EMEA sites.
  • Support the establishment of a Packaging Testing Laboratory in the Galway site.
  • Support the integration of the team into the site QMS.
  • Provide direction for documentation Control, CMS (Change Management System) and CAPA processes.
  • Manage communications with regulatory bodies such as BSI.
  • Provide leadership in the preparation for and during audits. Take the lead and front the team’s participation in audits.


  • Bachelor’s degree / HETEC Level 8.
  • A minimum of 5 years’ relevant experience in a Design Assurance - Quality Engineering field in a medical device or other FDA 21 CFR 820 or ISO 13485 regulated environment.
  • Must have experience in the preparation for and participation in ISO audits.
  • Experience in packaging and labelling design assurance very desirable.
  • Qualified auditor to FDA 21 CFR 820 or ISO 13485 desirable.
  • Demonstrated ability to deliver results, meet deadlines and expedite critical project completion.
  • Strong technical capabilities.
  • Strong people and communication skills.
  • Proven ability to work well as part of a team and on own.
  • Ability to lead virtual teams, including cross-site teams.
  • Strong written and verbal communication skills, with ability to communicate effectively to multiple levels of the company.

For further information contact James Cassidy [email protected] or call in confidence 0860204322