Title: Senior Quality Engineer
Location: 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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