R&D Quality Engineer

Brightwater

Limerick, Clare

A leading Diagnostics company in Clare requires a Quality Engineer with an R&D background for a Maternity Cover contract. Responsibilities: Include but are not limited to the following: Responsible for the support of the Design Control Process, including design change, within all areas. Act as quality representative on design projects. Review design projects at each phase of the Design Control process for compliance and ensure compliant closure of Design History Files (DHFs. Support R&D, System integration, Packaging Development and Customer Support from a QA perspective. Aid in updating all Design Control and R&D procedures/systems, as well as above mentioned departments, to ensure compliance with regulations and global procedures. Training staff on the specific requirements of the Design Control process in and regulatory or standard requirements. Conduct internal audits to ensure compliance of R&D and other technical areas as appropriate (System Integration, Packaging Development and Customer Support) with ISO13485 and FDA quality requirements. May act as a Risk Management Specialist. May act as an FMEA facilitator. Completion of Post Market Surveillance reports. Duties as prescribed by the R & D Quality Manager. Education and Experience: 3rd level qualification in Science, Engineering or Quality Assurance. Minimum of 2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment. Desirable to have previous experience in IVDDs, Design Controls and/or Risk Management. Excellent interpersonal / communication skills. Strong team member with the ability to identify and drive quality improvements. Excellent Planning and Organisational skills. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2586 days ago