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Quality Engineer - Senior, Limerick



Limerick, Ireland 

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€0.00 - €0.00

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Job Description:

Global Medical device company based in Limerick, Ireland - actively looking for Senior Quality Engineer. The candidate provides quality leadership and support to business units. Leads root cause investigation activities and drives continuous improvements.

The Job:

* Business Unit Non-Conformance (NC), CAPA, Complaints and Validations management.
* This includes investigations related to NC’s and complaints, trending of same and assessing need for CAPA.
* Responsible for investigation/disposition of on hold product and material (including supplier related holds) up to and including escalation to MRB
* Support both Internal and external audits, act as Business Unit Subject Matter Expert.
* Support quality improvement initiatives such as process and product characterisations that lead to continuous / cost improvements.
* Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
* Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSR's, ISO 13485, etc.

Have You:

* A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
* Requires 5-8 years related experience.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Experience with a proven track record of implementing appropriate risk mitigation.
* Experience working in both an FDA and European regulatory environment is preferred.
* In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
* Strong knowledge of statistical software packages.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Aleksas Kremenskas on +353 (0)87 2727949 or send your CV to akremenskas@berkley-group.com
Company Info
Berkley Recruitment Group
Mill House, Carrigrohane, Cork T12 C672
Cork, Ireland
Phone: 00353214289600
Web Site: www.berkley-group.com
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