We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
•Within the Coronary Design Assurance Group, we focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the coronary devices we develop, is assured and maintained throughout the product lifecycle.
• Manage all equipment and related systems in the DA ageing area.
• Responsible for creating and executing the equipment/software validation documentation including URS, Risk Assessment, OQ and IQ documents.
• Responsible for identifying, installing and qualifying equipment/software upgrades including equipment/software upgrades such as a remote monitoring system.
• Support process improvements project for the Design Assurance Age Area.
• Support Age study management
• Lead or support root cause investigations & drive problem solving efforts for Equipment test issues.
• Support the DA Lab Equipment team to identify new equipment and technology development initiatives that will drive continuous improvements throughout all the departments areas.
Education & Experience
• Minimum of Degree level 8 in Engineering / Science or related discipline with a minimum of 2 years of relevant experience.
• Experience working in the medical device or other regulated industry.
• Experience in design/development, problem solving and maintaining electro-mechanical manufacturing or test equipment.
• Experience of equipment design, verification & validation activities in medical device or other regulated industry.
• Experience of software configuration & validation activities in medical device or other regulated industry is desirable.