Quality Engineer

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I am working closely with an innovative medical device start-up in Galway who are one of Europe's leading developers in the field of neurovascular medical devices. There's never been a better time to join the team, with manufacturing ramping up due to growth.Located in the heart of Galway's medtech hub, the company have moved to a new facility to accommodate the increase in headcount and product development. They truly care about their patients and are looking for a dedicated Quality Engineer to join them. As Quality Engineer, you will fulfil the company's quality assurance responsibilities as part of the Quality team.Some of your key responsibilities will include:* Experienced in process validation techniques including risk management, statistical techniques in compliance with regulatory requirements.

* Lead process risk management process in compliance with EN ISO 14971 and preparation of risk management files and FMEAs.

* Responsible for the compilation and execution of Process Validation Protocols in conjunction with manufacturing.

* Supports Supplier Qualification, Assessment and Audit process at key Suppliers.

* Establish and maintain incoming, in-process & final inspections requirements and support design and validation test requirements as required.

* Generates NCRs and CAPAs for product defects and non-conformities observed and follows up to ensure effective closure.

* Managing sterilization activities, responsible for sterilization evaluation documentation and product release.

* Supports the management of all calibration and maintenance programs for all equipment.

* Manages validation and monitoring activities associated with particulate and biocontamination control.

* Manages change requests in a timely manner and ensures effective closure.

* Drives changes in procedures and standards to facilitate Drives the metrics system / trending for all quality system measurable.

* Interfaces with all departments (including Production, Design & Regulatory) on product development, transfer and improvement projects as required.

* Supports the design verification process including reviewing protocols, reports, design and quality documentation supporting product development.

* Support various Quality Management System activities including internal audits.Requirements:

* Degree in Biomedical Engineering/ Science/ Quality

* 2 years + experience as a Quality Engineer or similar role in a medical device manufacturing environment.

* Knowledge of Medical Device Quality Management System Requirements ISO 13485, MDD 93/42 EEC, 21 CFR Part 820, CMDR.

* Strong technical skills and analytical problem-solving ability combined with attention to detail to achieve project deliverables.If this seems like the perfect role for you, please apply directly below and I will contact you with further details.**EU Passport / Stamp 4 Visa Required** 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