Title: Senior Quality EngineerLocation: Dublin 1 (Hybrid working)Company: My client is developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR). It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events, and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity.Responsibilities:Support the development, implementation, and maintenance of the QMS in accordance with relevant standards and regulations (e.g., ISO 13485).Conduct internal audits to ensure compliance with established quality procedures and drive continuous improvement initiatives.Develop and implement risk management processes to identify, assess, and mitigate risks associated with medical device development and manufacturing.Creation and management of QMS documentation, including product dispositions, protocols, and reports.Ownership for Nonconformance process and support for other Quality processes internally.Support for validation, preventative maintenance, and calibration of equipment.Support for Design Verification activities and other Design Assurance related activities as required.Management of manufacturing issues, including leading root cause investigations, ownership of non-conformances, and CAPAs.Other related activities as required.Requirements:4+ years of experience in a Quality role in the Medical Device industry.Bachelor's degree or equivalent in Science, Engineering, or a related discipline; advanced degree preferred.Does this sound like your next career move? For more info, forward your application or contact me at 087 0612325 OR thomas.gallagher@lifescience.ie.
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