Quality Engineer - Contract

Posted 30 November 2023
LocationCounty Westmeath
Job type Contract
DisciplineEngineering Leaders and Specialists, Life Sciences & Engineering Technologies
ContactOlivia Rogers

Job description

Our client is a global medical device organisation based in Co Westmeath and is actively hiring for a Quality Engineer for a contract role.

The Position

You will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems.

Responsibilities will include:

  • Initiating and completing technical activities and cost savings as part of process improvements through the update of risk documentation, procedural updates, test methods, process/software validation etc., that have a significant impact to the business.
  • Initiating, reviewing, and approving change controls.
  • Performing, analysing and interpreting statistical data using an understanding of statistical tools and methods.
  • Developing a strategy and implementing appropriate sampling methods.
  • Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering.
  • Ensuring compliance is maintained for Product Manufacturing, Packaging and Labelling.
  • Performing internal and supplier audits.
  • Supporting and participating in external regulatory body audits, e.g., ISO and FDA
  • Creating and analysing data for Quality Metrics.
  • Complying with all relevant training required and adhering to relevant associated documentation.
  • Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Following strict adherence to the requirements of CGMP.
  • Actively contributing to the enhancement of compliance initiatives for areas of responsibility

The Person

  • 2-3 years' experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments is preferable.
  • Strong computer skills (MS Excel, PowerPoint, Word etc.)
  • Familiarity with statistical tools such as pareto charts and trend charts.
  • Familiarity with FMEA's (failure mode and effects analysis), and root cause analysis tools.
  • Experience with problem solving techniques.
  • Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates.

The Benefits

  • Competitive salary.
  • 9-month contract.

To discover more about this opportunity please apply online or contact Olivia Roger at HRM on +353 1 6321802 for a confidential discussion.