Our client, a growing medical device organisation based in Galway are seeking an experienced Software Quality Engineer. This role will be to monitor all phases of the medical device development process to ensure that the software design, development, and maintenance adhere to relevant regulatory requirements, standards, and guidance for all markets.
This is a contract role that is remote based to support on a specific project, providing technical expertise.
Key Responsibilities would include:
- Design and execute systems, test plans, scenarios, scripts or procedures to check for issues.
- Develop testing programs that address areas such as database impacts, software scenarios, regression testing, negative testing, unit testing and integration or system testing, interoperability testing, error or bug retests, or usability.
- Document software development and maintenance procedures to ensure replicability and compliance with standards e.g. FDA & ISO 14971, 62304, 60601-4-5, HIPPA, GDPR.
- Perform and document risk analysis to regulatory and procedural requirements
- Generate or coordinate software deliverables in line with ISO 62304, including but not limited to software requirements, specifications, verification/validation test plans, record test progress and results, resolution of failures or deviations with relevant quality personnel.
In order to be considered for this exciting daily rate Software Quality Engineer role, specific requirements for the successful candidate would include:
- Degree (L8) qualified in engineering, science, or a technical equivalent
- Minimum of 5+ years relevant within the medical device sector in a relevant role
- A thorough understanding of QA testing environments and software development life cycles in the medical device industry
- Experience working within a regulated environment, preferably in the medical device industry
What's on offer:
- Exciting daily rate contract role within a growing medical device company
- Opportunity to work within a technical team giving you access to build your portfolio within the medical device industry.
To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.