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Quality Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 21778

Our client based here in County Galway are looking to hire a Quality Engineer.


The Role:

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.


Responsibilities:

  • 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.

  • 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

  • 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.

Qualifications

  • 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.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717