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A Quality Engineer is required by CareerWise Recruitment for our Cork based client.

The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations.

* 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.

* Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.

* 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.

* Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.

* Approve IQ, OQ, PQ, TMV or Software Validation.

* Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

* Ensures effective quality strategies are created for the validation of test methods, process and design.

* A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience.

* Experience working in both an FDA and European regulatory environment is preferred.

* This position will require relevant experience working in manufacturing/operations.

* A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

Please call Lisa Casserly today for further information on 091-339136 or email:
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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