Senior Quality Engineer
Life Science Recruitment
- Northside Dublin
- Permanent
- Full-time
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.