Our Client, an exciting medical device start up in Galway City is hiring a Quality Engineer.
The successful candidate will support process quality and design assurance. The level of seniority can be tailored to the expertise of the suitable candidate. Collaborating closely with R&D, Clinical, Regulatory, and Manufacturing Engineering teams, you will provide essential quality expertise for our clients products. Your role will also involve contributing to design considerations for manufacturing and assembly. Most importantly, you should enjoy working in a dynamic, fast-paced environment, be enthusiastic about engaging with people, and excel at taking ownership to deliver projects on time, ultimately making a meaningful impact on patients' lives
Responsibilities include but are not limited to the following:
Ensure smooth transition of activities from design to manufacturing e.g. transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc.
Support Design Verification and Design Validation testing and associated methods.
Together with the R&D team, plan & support builds for R&D testing, product verification, clinical trials and commercial use of patient-facing medical devices.
Lead the transfer of an assembly line for electromechanical medical device(s), with guidance from the Project Manager and Quality Director.
Support validation of equipment and processes as required.
Work with existing and future external manufacturing partners and suppliers.
Continually look for opportunities to optimize processes.
