Quality Systems Engineer
Brightwater
Limerick, Galway
A multinational Medical Device client in Galway is seeking a Quality Engineer to bolster it`s Quality team. A strong salary and benefits package is on offer for the right candidate. About the Job: Quality support to assigned product development teams. Provision of functional input into risk management processes such as FMEA development, etc. Development of risk-based product/ process validation protocols for existing and new products/ processes. Assistance with site to site manufacturing transfers. Review and verification of quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas. Provides guidance on equipment calibration procedures as relevant. Provides guidance on inspection & test methods and associated sampling plans, etc. Performs analysis of inspection data and associated implementation of ship-to-stock program on relevant incoming components. Non-conforming product review and disposition, associated investigation and root cause analysis, and implementation of appropriate and effective corrective actions. Initiation, review and approval of document change controls CAPA Management. Performance of internal audits of the QMS. Provide guidance and support on audit outcomes as relevant. Performance of supplier audits and associated supplier management including supplier corrective action responses, etc. Performance of analysis on QMS data in prep for management review. Working with both suppliers and customers on the resolution of product quality issues and quality improvement programs. Some travel required. About You: Bachelor`s degree in science-related discipline or equivalent. 3+ years relevant experience working in medical device-related quality function. QMS Auditor Certification desirable. Product and Process Validation, including FMEA, DOE, Test Method Validation, sampling plan analysis, etc. Risk Management for Medical Devices and associated tools Six Sigma Problem-Solving Methodologies. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
1862 days ago