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


Company:
My client are a Medical Device company in a growth stage. 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.



Culture:

• An inclusive work environment, where all the employees are valued, supported, and encouraged.
• All employees have a seat at the table and have influence.
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be at the forefront of a technology that can positively impact the treatment of one of the world's most devastating diseases

• 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 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, implementation of corrective actions, and closure.

• Degree in Engineering or Science discipline.
• 5+ years’ quality or manufacturing experience in the medical device industry
• Thorough knowledge of Good Manufacturing Practice as described in US and European regulations for medical device manufacture.
• Excellent knowledge of the application of ISO 14971; Risk Management, throughout the QMS.
• Demonstrated ability to make challenging decisions to support continued supply of products, while also maintaining compliance.