Title: Quality Engineer
Location: Galway business park, Galway
Benefits: Salary, share options, pension, hybrid working and healthcare


Company:
My client are a growth stage medical device company, dedicated to improving the quality of life for stroke patients. Developing innovative catheter-based technology to extract blood clots from the brain following an Acute Ischemic Stroke, recently received FAD approval.


Overview:
As a Quality Engineer you will provide support in quality systems, supplier quality and manufacturing activities with a focus on continuous improvement of products and processes. They will support the execution of initiatives and projects to enhance quality performance within the business,



Responsibilities:

• Support the maintenance of a quality management system that complies with the Medical Device Regulation (MDR) EU 2017/745, the FDA Quality Management System Regulation 21 CFR 820 and ISO 13485.
• Lead quality activities related to outsourced manufacturers and suppliers to ensure compliance is maintained for Perfuze products.
• Lead risk management activities including hazard/failure mode effects analysis.
• Drive risk-based problem solving to assure product quality and patient safety through both design activities and manufacturing processes.
• Work closely with cross functional engineering colleagues to lead product transfer quality deliverables.
• Lead process verification and validation activities in accordance with quality system policies and practices.
• Own and manage internal and supplier driven non-conformances (NCs) and CAPAs, ensuring timely containment actions, corrections, root cause investigation