Quality Engineer

Job Description

I am seeking a Quality Engineer to join a medical device company in Dublin at their centre of excellence for manufacturing.

This person will be actively involved in product and process development, non-conformance investigations and consulting with key customers. You will also work closely/coordinate with QA and QC approving process validation, managing complaints, participating in change controls, and supporting process improvement projects,

The Quality Engineer will have a relevant degree in science or engineering with minimum 2 years' experience in a similar industry. Previous experience in an ISO 9001/2000 or ISO 13485 is essential. Knowledge of SPC and six sigma desirable with experience in preparing technical documentation. CAPA system management and knowledge of FDA requirements for audits also necessary. Experience with SAP and track wise advantageous.

Quality Engineer Responsibilities:

• Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements
• Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue
• Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate
• Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases
• Consult with relevant personnel regarding flow of product through QC department and other issues that arise
• Review, analyse and report on relevant customer complaints and institute corrective actions

If this role is of interest, please 'apply now' or contact me to discuss on 021 2300 300 or at aodriscoll@morganmckinley.com

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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