Design Assurance Engineer
Design Assurance Engineer – Growing MedTech Company. Responsibilities. Perform technical reviews of design files and labelling, participating in design reviews and providing leadership for design activities. Review design risk management documents. Support test development and validation activities. Provide approval for record, tests, validation, reports and design technical files. Act as lead for product design transfers and developing the validation strategy. Support external audits from notified bodies and FDA audits. Requirements. Degree in engineering or science with 2 years’ experience working in a medical device or pharmaceutical environment. Must have an ISO13485 or FDA QS regulatory experience. Software validation experience preferable but must have excellent data analysis skills. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: firstname.lastname@example.org. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.
73 days ago