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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Quality Engineer


Reference:TG - Senior Quality Engineer Location: Dublin
Dublin City Centre
Dublin Greater
Dublin North
Dublin South
Dublin West
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, QA Engineer, QA RA Engineer, QA Specialist, QA Validation Specialist, QE Manufacturing Engineer, Quality Engineer, Quality Manager

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


Requirements:
  • 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.

Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR [email protected]