Design Assurance Engineer Iii
Design Assurance Engineer III Job - Permanent Position with a fantastic medical device company in Galway - Remote Working/Hybrid Option Available! Your responsibilities as a Design Assurance Engineer will include: Review and remediation of current product offerings to ensure compliance with MDR requirements. Design Assurance support in assigned Operations and R&D Projects. Leading Risk Management activities for assigned projects. Initiate, develop and implement quality system improvements in assigned Quality System processes including (but not restricted to) Post Market Surveillance, Test Method Development, Risk Management, Real Time Aging. Providing support for QA system activities including audits, system reviews, and maintenance of the QMS. Providing guidance, direction and supervision to QA Technical Staff where appropriate. Compilation and analysis of post market surveillance reports. Other related duties and tasks as required. Qualification/Experiences: Bachelor’s Degree in Engineering, Science or equivalent technical qualification. Minimum of 3-4 years’ experience in a similar role / environment. Good working knowledge of quality systems and their application in a Design/manufacturing environment. Experience of statistics and a good working knowledge of test method validation. Good working knowledge of ISO13485, ISO14971 and FDA QSRs. You should also have the following abilities/skills/qualities as a Design Assurance Engineer: Ability to work under strict time constraints; meet deadlines in a timely manner with minimal guidance. Team player: Ability to work and communicate effectively as part of QA and cross functional / organisational teams; be flexible with a ‘can do’ attitude. Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external. Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to clearly and informatively write technical documentation, routine reports, correspondence, procedures and work flows. Present numerical data effectively. Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks. PC Skills: Standard offices packages and ability to understand and learn customized computer software programs.
65 days ago