Quality Assurance Engineer

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What you need to know

Our client is experiencing huge growth in their device design, development and manufacturing operations and is looking to hire a Quality Assurance Engineer. This is a key position within the Quality team charged with establishing, implementing and maintaining the Quality System on site.

This is a permanent job with a company located in Co Galway and who are experiencing huge growth due to their innovative new product introductions to the medical device market.

Your new job

Reporting to the QA & Regulatory Affairs Manage you will support all QA activities as part of an overall project team. You will continually promote a culture of compliance and excellence within the company to meet customer requirements and the applicable regulatory standards, as well as participating in new product/technology developments.

Key duties & responsibilities:

  • Partner with R&D and Process Engineers to ensure that the transition of products through R&D and sister sites, product approval and manufacturing scale up are smooth, timely and cost effective.
  • Participates in new product/technology development and supports the QA activities as part of an overall project team.
  • Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
  • Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met
  • Conduct root cause analysis and implements corrective actions
  • Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
  • Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.

What are we looking for?

  • An Engineering or Quality Assurance Degree or equivalent experience
  • A minimum of 3 years post qualification experience as a Quality Assurance Engineer within a Medical Device or regulated environment
  • A good team player, who works well in a small team environment, must be able to work effectively with and influence peers in other Departments
  • Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements
  • A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation
  • An analytical approach with attention to detail, while maintaining awareness of longer-term objectives.

Apply for this job now or get in touch with Gareth on 090 6490485.

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Recruitment Consultant: Gareth Morris

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