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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]
Project Manager Engineering Manufacturing Executive Mayo Connected Health Limerick PhD Clinical Research IT Cork Medical Affairs Chemistry Biopharmaceutical Academic Life Science Sales and Marketing Diagnostics Quality Assurance Laboratory Scientist Scientist Dublin Cork City Sales and Marketing Supply Chain Scientific Quality Engineering Academic Microbiology Pharma Sales Pharmaceutical Medical Device Quality Control Allied Healthcare Product Development Engineer Supply Chain Biotechnology Packaging Engineer Validation Engineer
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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