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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: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | 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]
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