Quality Assurance Engineer
Our client, an innovative and expanding organisation in Galway offers total solutions to ensure the design and manufacture of market leading products. With a world class development team this organisation is an exciting place to be due to expansion on-going and new projects in the pipeline at their Galway site.
Our client is currently seeking a Quality Assurance Engineer to join a large collaborative team at their facility in Galway. You will report to the Quality Assurance/Regulatory Affairs Manager and you will be a key member of the Quality team being involved in project design plans and new product development projects.
As the Quality Assurance Engineer your key responsibilities will be to:
- Promote compliance and excellence within the company to customer requirements and the applicable regulatory standards
- Participate in new product/technology development and supports the QA activities as part of an overall project team
- Execute the project design plans, protocols and generate reports for new product development projects as well as design/process changes
- Partner with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective
- Define and implement Quality standards and specifications and ensure Regulatory requirements are met
- Develop and execute validations in line with regulatory standards to include equipment, process and product validations
- Conduct root cause analysis and implement corrective action in a timely manner and conduct audits, including closing out audit findings and creating and determining proper corrective and preventative action
- Liaise with R&D, Operations & Customers in the development, customisation and control of product labelling
The successful Quality Assurance Engineer should possess:
- 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
- Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements
- The ability to stay connected to multiple projects simultaneously
- Health Insurance
- Training opportunities
To learn more apply online or contact Orla Boyle at HRM directly on +353 91 782110 for a confidential chat.
Salary: On Application