Quality Assurance Engineer

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What you need to know:

A multinational manufacturing company based in Athlone, Co. Westmeath are looking for an ambitious and experienced Quality Assurance Engineer to join their ever-growing team. This is a fantastic opportunity to join a market leading company.

 

Your new job:

As a Quality Assurance Engineer you will:

Provide Quality support to processes, materials and products. You will be in charge of the implementation of and compliance to the Quality Management Program. You will have experience with regulatory requirements such as ISO, FDA and JPAL.

 

Responsibilities include:

 

  • Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for new and existing products.
  • Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
  • Review change controls for validation impact.
  • Use knowledge of statistics to assist with validation developments and process improvements
  • Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
  • Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
  • Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
  • Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
  • Internal Audits and improve site Quality Metrics.
  • Follow strict adherence to CGMP and EHS policies.
  • Comply with all relevant training.

 

 

What are we looking for?

You will:

 

 

  • Bachelor’s degree in an engineering or science discipline.
  • At least five years’ experience in a medical device, FDA or ISO 13485 registered environment.
  • 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 highly technical information, both verbally and in writing, to both non-technical and technical associates.

 

 

 

 

Apply for this job now or get in touch with Jack Linnane on 09064 90485.

 

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Recruitment Consultant: Jack Linnane

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