Senior Quality Engineer

Life Science Recruitment; Eu; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A medical device company is seeking a Senior Quality Engineer to support and maintain the Quality Management System (QMS). You will conduct audits, develop risk management processes, and manage non-conformance issues. A Bachelor's degree and over 4 years of experience in the Medical Device industry are required. This position offers hybrid working opportunities.

Qualifications

• 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.

Responsabilités

• Support the development and maintenance of the QMS.
• Conduct internal audits to ensure compliance.
• Develop and implement risk management processes.
• Creation and management of QMS documentation.
• Support Design Verification activities.

Connaissances

Quality Management System (QMS)

Internal auditing

Risk management

Documentation management

Root cause analysis

Formation

Bachelor's degree in Science, Engineering or related discipline

Description du poste

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
• Bachelor's degree or equivalent in Science, Engineering or a related discipline, advanced degree preferred.

If you are interested in this position, please contact us for more information.