A leading medical device organisation on the West side of Galway is seeking a Quality Engineer to join their business on a permanent basis
- Quality Assurance oversight of operational activities, production, and validations and Technical Services projects to ensure QA systems and Manufacturing/Engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.
- Writing and reviewing SOP’s, Visual Standards and Guidance Documentation
- Ensuring process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes
- The following while serving as the QA representative on validation and technical services projects
- Providing QA review and approval of site process and equipment validation documentation such as protocols, deviations and final reports.
- Providing QA support for change controls
- Managing and coordinating QA support during the execution of the project
- Serving as the QA liaison with all vested parties including QA/QC laboratories, IT, Manufacturing, and Engineering
- Serve as the QA representative on Validation and Technical Services projects.
- Serve as the Quality Assurance Review site process and equipment validation documentation representative and approver for protocols, deviations, and final reports
- Managing and coordinating QA support of any Supplier Quality and Distribution Quality Issues and investigations
- Management and oversight of Supplier Quality agreements
- Supporting change control activities associated with processes and equipment validations.
- Managing and coordinating QA support for new and existing process equipment validation implementations
- Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution.
- Five (5) years of relevant experience, working in areas such as process validations, technology transfer or quality engineering.
- Advanced user of Excel and Statistical programs such as Minitab.
- Experience in a GMP regulated environment preferred.
- Experience in an aseptic manufacturing environment preferred.
- Ability to work take initiative with a pro-active strategic approach to challenges
- Demonstrated ability to apply analytical methods to business issues
- Attention to detail
- Ability to develop relationships internally and externally to achieve goals
- Broad understanding of Quality Engineering and a strong business acumen
*Benefits will be included for this position along with a salary in line with your experience.
For more information, please contact Elaine Dolan for a confidential discussion.