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
CTO
Galway
Quality Engineer
Dublin South
Project Manager
Kilkenny
Process Engineer
Limerick
Administration Support
Dublin North
QC Trainer
Cork
Planner/Buyer
Limerick
R&D Engineer
Dublin
Program Manager
Westmeath
Risk Manager
Dublin
Consultant
Cork
R&D Engineer
Dublin
Biostatistician
Dublin City Centre
Senior Social Work Practitioner
Republic of Ireland
CSV Engineer
Dublin
Quality Engineer
Limerick
QC Chemist
Dublin
QA Specialist
Dublin
Quality Manager
Dublin South
API Purchaser
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 applications@lifescience.ie
Details

Senior Quality Engineer


Reference:SMC035641 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Senior Quality Engineer

Summary

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.

Duties

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality
• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports new product introduction as part of design transfer.
• Lead and maintain Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Approve IQ, OQ, PQ, TMV or Software Validation

Experience & Education
• A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.



If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480