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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Quality Engineer


Reference:TG - SQE - Galway Location: Galway
Galway City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, EHS Engineer, QA Engineer, QA RA Engineer, QA Specialist, QA Supervisor, Quality Engineer, Quality Manager

Title: Senior Quality Engineer
Location: ATU iHub Galway City.
Benefits: Top Salary, share options, hybrid working, flexitime and bonus


Company:
My client a clinical-stage CE Marked and FDA approved medical device manufacturer. Currently seeking an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease.


Product:
My clients first product is a mechanical endovenous infusion catheter that enables precise and efficient delivery of physician-specified agents in superficial veins in a single-use, disposable catheter-based solution significantly improving the quality of life for millions of sufferers across the globe



Responsibilities:

  • Development, implementation and continuous improvement of an efficient, work-flow based and fully compliant quality management system in accordance with ISO 13485, and 21 CFR Parts 808, 812, 820 to meet the requirements of all stakeholders.
  • Planning, implementation and coordination of quality assurance to include quality specifications, processes, training, CAPA, validation & verification procedure documentation, and material safety specifications.
  • Coordinate and support execution of supplier assessment, selection and qualification activities.
  • Support internal and external audit activities.
  • Review and revise Quality Management System documentation to keep current with industry standards.
  • Apply knowledge of design control and risk management principles and quality engineering techniques throughout the product development process.
  • Support quality-related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies, and test methods).
  • Preparation and maintenance of documentation in compliance with appropriate regulatory requirements.
  • Understand and apply Risk Management concepts used to ensure Product Safety requirements in accordance with EN ISO 14971.



Requirements:

  • Bachelor’s degree in science, engineering, or a related field.
  • Minimum 5 years of quality assurance experience for a Class II medical device.
  • Excellent understanding of Quality Systems with a proven track record of running, implementing or improving Quality System Processes.
  • ISO 13485 Lead Auditor Training is desirable.
  • Experience of working as an agile member of the R&D quality team across GMP, process validation, change control, CAPA, Auditing, and Risk Management (including FMEA) and electronic document control systems



Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]