Quality Systems Manager

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 partnering with a well-funded, high-growth Cork-based startup at the forefront of AI-driven healthcare innovation. Now entering an exciting scale-up phase and they are seeking an ambitious Quality Systems Manager to build and lead its quality function from the ground up.

As a Quality professional coming from regulated Medech, you will shape the Quality Management System (QMS) for a next-generation healthcare technology, working at the intersection of AI, software, clinical research, and medical device regulation and play a pivotal role in establishing quality and compliance frameworks that enable innovation while preparing the business for future certification, regulatory submissions, and commercial growth.

Responsibilities

Build & Scale the Quality Function

• Design, implement, and continuously improve the company's ISO 13485-compliant QMS.
• Develop core quality processes including CAPA, document control, change management, supplier quality, training, and non-conformance management.
• Lead internal audits and support external regulatory and certification audits.
• Champion a culture of quality across a fast-paced, entrepreneurial organisation.

Partner with Product & Engineering Teams

• Embed quality and design control processes throughout the product development lifecycle.
• Support software and AI-enabled product development activities, ensuring compliance without compromising agility.
• Maintain Design History Files (DHF), traceability matrices, and validation documentation.

Drive Compliance & Regulatory Readiness

• Support risk management activities in line with ISO 14971.
• Collaborate with external regulatory experts to prepare for future MDR/FDA submissions and certification activities.
• Ensure the organisation remains inspection and audit ready as it scales.

Enable Clinical & Commercial Success

• Support clinical validation activities and evidence generation.
• Provide practical quality guidance to multidisciplinary teams spanning software, data science, clinical, and research functions.

Requirements:

• 5+ years' experience in Quality Assurance, Quality Systems, or Compliance within medical devices, digital health, SaMD, or another highly regulated industry.
• Strong knowledge of ISO 13485 and quality system implementation.
• Experience with audits, CAPA, document control, risk management, and regulatory compliance.
• Comfortable operating in a startup or scale-up environment where structure is being built and priorities evolve quickly.
• A proactive, hands-on mindset with the ability to influence cross-functional teams.
• Experience building or scaling a QMS in an early-stage company.
• Knowledge of SaMD, AI-enabled healthcare technologies, IEC 62304, ISO 14971, EU MDR, FDA requirements, and the EU AI Act.
• Experience supporting regulatory submissions, clinical validation studies, or acting as PRRC.

This is an amazing opportunity to join a mission-driven startup at a critical growth stage and have a direct impact on the development of groundbreaking healthcare technology. You'll work alongside experienced entrepreneurs, scientists, clinicians, and engineers, helping bring innovative AI-powered solutions to patients while building the quality foundations of a future industry leader.