Our client based here in County Galway are looking to hire a Quality Engineer.
As a Quality Engineer, you will provide support in quality assurance, control, and manufacturing activities with a focus on continuous improvement of products and processes. You will support the execution of initiatives and projects to enhance quality performance within the business, ensuring compliance to regulations and standards.
Quality support to assigned product development teams ensuring product manufactured conforms to quality standards, specifications, customer expectations, and associated regulations, e.g. FDA, ISO and MDD
Non-conforming product review and disposition, associated investigation and root cause analysis, and implementation of appropriate and effective corrective actions
Develop metrics around (Quality system) processes and drive improvements in these metrics
Initiation, review and approval of document change controls.
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
Working with both suppliers and customers on the resolution of product quality issues and quality improvement programs
Performance of analysis on QMS data in prep for management review.
Review and verification of quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas
Provision of functional input into risk management processes such as FMEA development
Development of risk-based product/ process validation protocols for existing and new products/ processes
Provides guidance on equipment calibration procedures as relevant
Provides guidance on inspection & test methods and associated sampling plans
Performs analysis of inspection data and associated implementation of ship-to-stock program on relevant incoming components
Assistance with site-to-site manufacturing transfers.
Bachelor's degree in science-related discipline or equivalent
3+ years relevant experience working in medical device-related quality function QMS Auditor Certification desirable
A motivated team player; builds and maintains effective collaboration
Injection Moulding knowledge experience is desirable but not essential.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
091 706 717