Title: Senior Quality Engineer
Location: Dublin 1 (Hybrid working)
Company: My client are 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

• 4+ years of experience in a Quality role in the Medical Device industry
• Bachelors degree or equivalent in Science, Engineering or a related discipline, advanced degree preferred.