Senior Supplier Quality Engineer Galway

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Role: Senior Supplier Quality Engineer

Industry: Medical Devices

Location: Galway

This is a highly collaborative position working closely with R&D, Operations and key suppliers to ensure the effective supply of high-quality finished product for development projects, clinical and commercial activities. Your role will be to support the Quality Manager in ensuring that product is manufactured, released and distributed in accordance with the relevant quality and regulatory requirements.

Job requirements

Principal Responsibilities

* Support the finished device manufacturing subcontractor and stent supplier to ensure that the product quality and regulatory requirements are met.

* Perform lot review and lot release activities.

* Review and contribute to process validation and risk management activities of the subcontractor and stent supplier.

* Provide manufacturing QA support to process and product development projects.

* Ensure that SCAR's, CAPAs, NC's and other open action items, are completed in a thorough and timely manner.

* Assess and process supplier and Veryan changes, ensuring product impact is appropriately considered.

* Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.

Must Have's:Manufacturing Quality experience

At senior level with 7 years experience in quality engineering of which at least 4 years should be in a manufacturing quality role.

Class III product experience essential

CAPA, Auditing and Risk Management experience per ISO 14971 (including FMECA).

Must be good with people and managing relationshipsEducation & Training

Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline.

Auditing Qualifications are desirable.

Note:

Some travel to Germany for 2/3 days at a time throughout the year. 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