Would you like to join a leading and well known Medical device comappny in Galway, to further develop your career? This is an excellent opportunty to combine Design Assurance and Post Market Sustaining Engineering.
• Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.
• Support teams to implement EUMDR requirements
• Guide & complete software validations for excel & business objects.
• Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You will assess the patient risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
• Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
• Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
• As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities. You will generate and approve change requests.
• Lead incident investigation analysis (IIA) and timely completion of same.
KEY SKILLS & EXPERIENCE
• We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and desirably with a minimum of 5 years relevant experience with a specific skill set (EUMDR & Excel validations).
• You are a dynamic team player, can work effectively and proactively on cross-functional teams.
• Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
• You are a good communicator and fluent in English, both in writing and speaking.
Kevin Silke | Tel: +353 (0) 1 5079255/strong>