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Title: Validation Engineer
Location: Collooney, Sligo
Benefits: Excellent salary, pension and Healthcare.Role:
The Validation Engineer for will implement and work on the sites quality management system to ensure their full compliance with MDR and 13485 regulatory standards.This person will support day to day operations in relation to validation and revalidation of the manufacture of wound care dressings and be a leader within the organisation on site for validation activities.Key responsibilities:
* Support, Maintain and improve the site validation program and ensure compliance to the quality requirements as set in the ISO 13485 and MDR
* Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations.
* Strong leadership skills to bring teams along with their understanding of validation activities, including Test Method validation, Packaging validation, software, IQ, OQ, PQ and overall process validation.
* Writing and reviewing protocols, reports deviations, supporting change control, and release to production after validation activities.
* Ensuring process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes
* The following is required in execution of the validation engineer role and related technical projects
o Providing SME review and approval of site process and equipment validation documentation such as protocols, deviations and final reports.
o Providing SME support for change controls in relation to validation
o Managing and coordinating validation support during the execution of the project
o Serving as the validation liaison with allQualifications:
* At least 4 years work experience as a Validation Engineer within in medical device industry
* A level 8 degree in a Quality, Science or Engineering disciplineWould you be interested in hearing more about this role and company?If so forward an up to date CV to the link provided or contact me on the details provided and we can organise a time that works for you to discuss further. 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