Quality Manager – Galway, IrelandTricardia are partnering with a growth-stage medical device company that is transforming stroke care. They have commercially launched and are developing innovative catheter-based technology to improve outcomes for patients following Acute Ischemic Stroke. This is a unique opportunity to join a collaborative, inclusive team where every voice matters and to play a key role in advancing technology that could change lives.About the RoleThe Quality Manager will lead all quality assurance processes across the organization, ensuring compliance with global medical device standards and driving continuous improvement in the Quality Management System (QMS). This is a high-impact, hands-on position with responsibility for oversight of internal and external audits, supplier quality, risk management, and quality support for device development projects.We are open to candidates who already have management experience or to Principal/Staff-level quality professionals who are ready to step into a management role.Key ResponsibilitiesServe as Management Representative in line with ISO 13485:2016.Act as Local Actor Administrator (LAA) for relevant regulatory databases.Report on QMS performance to top management and recommend improvements.Manage and maintain the QMS in compliance with ISO 13485, FDA 21 CFR 820, MDD, and MDR (EU 2017/745).Promote awareness of regulatory requirements and quality processes across the organization.Lead internal and external audit programs, including Notified Body and FDA inspections.Oversee Corrective and Preventive Action (CAPA) and Risk Management processes.Manage supplier quality activities, including onboarding, evaluations, audits, and quality agreements.Support quality operations at contract manufacturing sites and cleanroom operations.Oversee process validation, equipment control, receiving inspection, and non-conforming material processes.Drive continuous improvement initiatives across the QMS.Provide quality support for device development projects and regulatory submissions.RequirementsDegree in Engineering, Science, or a health-related discipline.2+ years management experience or demonstrated readiness for a management role (e.g., Principal/Staff-level professionals).Experience in quality assurance within the medical device industry.Knowledge of US and EU Good Manufacturing Practices and ISO 13485.Proficient in ISO 14971 risk management application across a QMS.Skilled in Class 8 cleanroom compliance.Strong decision-making skills to balance compliance with business needs.Excellent organizational, self-management, and prioritization skills.Effective communication across cross-functional teams and executive management.Experience driving continuous improvement initiatives.Hands-on mindset and proactive problem-solving approach.Why Join?Be part of a mission-driven team shaping the future of stroke care.Work in a collaborative and inclusive culture where your input is valued.Gain exposure to cutting-edge medical device technology and high-impact projects.