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.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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