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Quality Assurance Engineer

Job description

Quality Assurance Engineer

Work with an expanding medical device coating and in-vitro diagnostic company who are in the middle of a large NPI project. This role will be a short term contracting position assisting the Head of Quality in establishing, implementing and maintaining the QMS while also focusing on new protocols and processes. This role is perfect for someone with a sterilisation background.

Responsibilities: 

  • Work together with R&D and Process Engineer across the Galway and other sister sites regarding product approval and excellence
  • Promote compliance and excellence for customer requirements and regulatory standards
  • Be part of new product and technology development, supporting QA activities
  • Develop project design plans, protocols and generating reports for new product development projects
  • Define and develop quality standards and specifications to meet global regulatory standards
  • Conduct root cause analysis and manage CAPAs onsite
  • Implement continuous improvement for the site for manufacturing and quality activities

 Requirements:

  • An engineering or equivalent experience with 3 years or more experience
  • Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements
  • A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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