Design Assurance Engineer

Careerwise Recruitment

Mayo

We urgently need your help to fill a Design Assurance Engineer role at a leading multinational in Mayo. Our client seeks only an individual with a track record of excellent clinical skills and technical knowledge in a regulated industry. THE ROLE: * Lead the Design Review process in compliance to internal procedures including EU and FDA requirements. * Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records and Clinical Trial Records. * Generation and/or review of quality and technical documentation to support design activities. * Preparation of risk management documentation including Use and Design FMEAs as required. * Assist Regulatory Group as required with the preparation of regulatory submissions and clinical trial documentation. * Manage the documentation, product builds and records related to any clinical trials required including review of protocols and reports. * Interfaces with R&D, Clinical Marketing, Process Development and Manufacturing in a project core team environment providing technical and Quality systems input to the team. REQUIREMENTS: * Minimum 3-5 years experience as Design Assurance Engineer or similar role in a medical device company. * Working knowledge of EU and FDA requirements. Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

1843 days ago