Design Quality Engineer

CPL

Limerick

Design Quality Engineer. Job Summary. Our client in Annacotty, Limerick are looking for an experienced Design Quality Engineer with New ProductDevelopment experience. The Design Quality Engineer will assure that new product designs and the processes for manufacturing meet all requirements in relation to safety and efficacy. Main Duties: Represent quality interests and concerns on project teams. Participates in Risk Management activities throughout product lifecycle. Perform quality activities (risk management, FMEA, creation of documents,document review) according to project schedule. Reviews design control compliance requirements for NPD projects and all designelements. Heavy involvement in the development of DFMEAs, and supporting thedevelopment of PFMEAs. Performs DOEs and other statistical analysis to support product and processoptimization or determine causes of process variation. Initiate corrective actions asrequired. Participates in internal audit and supplier audit programmes. Development of robust action plans, projects and verification activities forelimination of potential risks, as required. Working with cross-functional teams to effectively implement NPD projects. Familiarity with regulations including ISO 13485, 21 CFR 820, ISO 14971 and IVDR. Provide advice and support to colleagues on quality matters. Represent quality department in company projects where required. Essential Criteria: A minimum of a Bachelors degree (Hons) in Engineering, Technology, Science orrelated discipline. (Level 8. Proven knowledge and experience (ideally minimum 5 years) of working with ISO13485, ISO14971, the IVD / IVDR: In Vitro Diagnostics Regulation and the FDAQSR including 21 CFR Part 820 and 21 CFR Part 11. Experience of FMEA, control plan development, Statistical Process Control (SPC)and capability analysis. Ability to manage competing priorities in a fast-paced environment. If youre interested in applying or want to know more about this job contact Darren Brown in CPL Limerick in complete confidence on 0874053774 or email your Cv to darren.brown@cpl.ie.

617 days ago