Quality Systems Architect for AI MedTech

Fastnet; Cork; On-site; EUR 90,000 - 130,000; Full time

Job summary

Fastnet is hiring a Quality Systems Manager to build and lead the quality function from the ground up in Cork, Ireland. You will design an ISO 13485–compliant QMS for a next-generation healthcare technology spanning software, AI, and clinical aspects.

The role partners with Product and Engineering, driving regulatory readiness for MDR/FDA submissions, and supports clinical validation activities while preparing for future certifications and audits in a fast-paced startup environment.

Qualifications

• 5+ years in Quality Assurance or Compliance in regulated health tech or medical devices.
• Strong knowledge of ISO 13485 and quality system implementation.
• Experience with audits, CAPA, risk management and regulatory compliance.
• Hands-on, proactive leader used to startup or scale-up environments.

Responsibilities

• Build, implement, and continuously improve an ISO 13485–compliant QMS.
• Embed quality processes across product development and software teams.
• Lead internal audits and support external/regulatory audits.
• Drive risk management, CAPA, document control, and training programs.

Skills

Quality Assurance

Quality Systems

Regulatory compliance

Audits

CAPA

Document control

Risk management

Job description

Fastnet is hiring a Quality Systems Manager to build and lead the quality function from the ground up in Cork, Ireland. You will design an ISO 13485–compliant QMS for a next-generation healthcare technology spanning software, AI, and clinical aspects.

The role partners with Product and Engineering, driving regulatory readiness for MDR/FDA submissions, and supports clinical validation activities while preparing for future certifications and audits in a fast-paced startup environment.