applications

Quality Engineer - Manufacturing Support

My client a leading Global Manufacturing Company with office based in Cork is currently seeking a Quality Engineer; the ideal candidate will have 2+ years experience in a QA role, Degree in Engineering Science or equivalent and a very strong level of analytical skills.

Main Duties & Responsibilities;

• Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.


• Ensure regulatory compliance in area of responsibilities to GMP of all medical devices regulatory agencies, i.e - FDA, IMB, SBI


• Ensure Compliance of QMS procedures within the business unit


• Lead Problem Solving meeting using the following : 4D, Six Sigma.


• Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.


• Drive and implement plant wide quality system improvements.


• Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.


• Provide functional expertise to other support function on quality related issues.


• Manage NCR Process.


• Interface with Suppliers for new processes, quality Issues and Process Improvements.


• Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.


• Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.


• Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.


• Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.


• Responsible for input to Quality Metrics.


• Evaluation of Customer Complaints (PER Investigation) as required.

If you would like more information on this role and many more please don't hesitate to contact Eleanor on 021 2300 302 or send your CV to jobs@brunel.ie