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
Sean McCarthy
Life Science

[email protected]
Connect with me on
Project Engineer
Project Engineer
Project Engineer
Head of R&D
R&D Manager
VP of R&D
Republic of Ireland
Process Engineer
Republic of Ireland
Regulatory Affairs Specialist
Republic of Ireland
C&Q Engineer
Senior CSV Specialist- Hybrid
Republic of Ireland
Quality Engineer
QA Manager
Snr R&D
Process Engineer
Engineering Technician
Dublin South
Quality Engineer
R&D Engineer
Limerick City
QA Contractor
Dublin City Centre
QA Specialist
R&D Manager
Senior R&D Engineer
Limerick City
Quality Consultant/Manager
Republic of Ireland
Project Engineer
PHD Chemist
R&D Design Engineer
Dublin South
NPI Manager
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]

Quality Engineer

Reference:SMC6559 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


•Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes.
• Support Quality and Validation activities for product transfers and new product introductions.
• Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
• Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
• Determine process inputs and factors for variation where process capability is required.
• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
• Develop pFMEA documentation to support processes as part of Validation process
• Partner with R&D and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
• Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
• Support root cause analysis activities related to material processes.
• Communicate effectively with global functions and internal team on actions and deliverables.
• Provide timely and accurate reporting and management of escalations as appropriate on project activities.
• Ensure all activities comply with GMP, ISO and quality system requirements.
• Ensure that all health, safety and environmental requirements are fulfilled.

Education & Experience

• BSc in Engineering or Science with ?2 years’ experience in a medium to high volume manufacturing environment
• 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
• Experience working in both an FDA and European regulatory environment is preferred with an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
• A thorough understanding of GMP/ISO and validation regulations.
• Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Problem solving engineering expertise (Six Sigma, SE or A3)
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.