Quality Engineer (West Galway)

COLLINS MCNICHOLAS RECRUITMENT

GALWAY

A leading medical device organisation on the West side of Galway is seeking a Quality Engineer to join their business on a permanent basis. Key Duties. 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. Key Requirements. 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. elaine.dolan@collinsmcnicholas.ie. 091 706 718. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1554 days ago