Quality Engineer Operations Galway

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Role: Quality Operations Engineer

Industry: Medical Devices

Location: Galway

This is a brand new permanent job opportunity with a key client of ours who are expanding their quality team as a result of continuous growth.The successful candidate will join the Operations Quality group and have responsibility for Operations Quality within their prescribed area of functional responsibility.

Your Responsibilities:

* Overall responsibility for production GMP standards and compliance.

* Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.

* Establishing inspection standards, plans, frequencies and test methods.

* Establishing and maintaining FMEA's.

* Preparing and updating Operations procedures and associated documentation.

* The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.

* Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.

* Maintain relevant documentation to comply with quality standards and customer requirements.

* Develop strong links with customer organisation's and other project stakeholders.

* Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.Your skills/experience:

* Degree in Quality or Degree in Science / Engineering.

* Experience within a similar role as quality engineer.

* 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.

* Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.

* New product introduction and manufacturing process transfer experience would be a distinct advantage.

* Quality experience in component and device manufacturing desirable.

* Excellent written and oral communication skills essential. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales