Title: Senior Quality Assurance 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.

• 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