Quality Assurance Engineer

Our client a global medical device organisation based in the West offer state of the art medical device components and products to their wide range of customers and patients, providing solutions to patients with debilitating diseases and improving quality of life.

The Role:

Reporting to the Quality Assurance Manager, you, the QA Engineer will provide ongoing support to the manufacturing team to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues. The scope of role will also include addressing any customer related issues identified in the manufacturing process and validation of new processes/products.

Key responsibilities will include:

  • Reviewing, updating and maintaining existing quality management processes and procedures
  • Initiating and driving Continuous Improvement programs
  • Hosting audits by external bodies (e.g. audits from customers, audits relating to certification to official standard e.g. ISO 9001, ISO 13458)
  • Investigations of non-conforming Material, Customer Complaints, CAPA investigation, analysis and improvements
  • Data Analysis and Trending, Statistical Process control, Root Cause Analysis and the implementation of Corrective Actions
  • Preparing and executing Process/Product Validations
  • Ensuring new product introductions and change controls are effectively managed in accordance with the ISO requirements when appropriate
  • Supporting the introduction of new product lines through development of Product Inspection Plans, Process FMEAs and Risk Management Plans

The Person:

  • A Degree in Science/Quality Assurance or equivalent
  • Minimum of 5 years’ experience in a Quality Engineering role, preferably in the Healthcare/Medical Device Sector
  • A capable individual looking for an exciting opportunity within a respectable global organisation that is willing to gain exposure to a wide range of quality aspects.

To discover more about this opportunity, apply now or contact Orla Boyle at HRM on +353 91 782 110 for a confidential discussion.

Salary: On Application Location: Roscommon