Quality Systems Manager

Organisation: Corca Health (based at UCC’s Innovation Centre)

Location: Hybrid (4 days on\-site, 1 day remote)

Contract Type: Full\-time, Permanent

Start Date: July 2026

Summary:

Corca Health is seeking a Quality Manager to lead the development, implementation, and maintenance of the company's Quality Management System (QMS) for an AI\-powered healthcare product focused on mental health and neurodevelopmental assessment.

The successful candidate will establish quality processes, maintain compliance with applicable standards, support product development activities, and work closely with external regulatory consultants to prepare the company for future medical device certification and regulatory submissions.

Key Duties and Responsibilities:

Quality Management System

• Establish, implement, and maintain the company's QMS in line with ISO 13485\.


• Develop and manage quality processes including document control, CAPA, change control, training records, supplier management, and non\-conformance management.


• Maintain quality documentation and quality records.


• Support internal audits and external audits.


• Drive continuous improvement activities across the organisation.

Design Controls \& Product Development

• Support implementation of design control processes.


• Maintain Design History File (DHF) and associated documentation.


• Ensure traceability between requirements, risks, verification, validation, and clinical evidence.


• Work closely with clinical, research, and software teams to embed quality processes throughout product development.

Risk Management \& Compliance

• Support risk management activities in accordance with ISO 14971\.


• Maintain risk management files, hazard analyses, and risk assessments.


• Ensure quality and compliance requirements are incorporated into product development activities.


• Support validation and documentation activities for software and AI\-enabled systems.

Regulatory Support

• Work closely with external regulatory consultants to support regulatory strategy and submissions.


• Prepare and maintain documentation required for regulatory reviews and submissions.


• Implement actions arising from regulatory guidance and gap assessments.


• Monitor and maintain compliance documentation required for regulatory readiness.

Clinical \& Validation Support

• Support quality oversight of clinical validation studies.


• Ensure appropriate documentation, records, and evidence are maintained.


• Support generation of evidence required for future regulatory submissions.

Cross\-Functional Collaboration

• Provide quality guidance across clinical, technical, and research teams.


• Deliver training on quality processes and procedures.


• Promote a culture of quality throughout the organisation.

Essential Criteria:

• Degree in Engineering, Life Sciences, Health Sciences, Quality, or related discipline.


• 5\+ years' experience in quality assurance, quality systems, or compliance within medical devices or another regulated industry.


• Experience implementing or maintaining quality management systems.


• Strong understanding of ISO 13485\.


• Experience with document control, CAPA, audits, and quality processes.


• Experience supporting risk management activities.


• Strong organisational, communication, and documentation skills.


• Ability to work independently in a fast\-paced startup environment.

Desirable Criteria:

• Experience in medical devices or Software as a Medical Device (SaMD).


• Familiarity with ISO 14971 and IEC 62304\.


• Experience supporting regulatory submissions or regulatory readiness activities.


• Experience building or scaling a QMS in an early\-stage company.


• PRRC Experience


• Familiarity with software


• Experience supporting clinical studies or validation projects.


• Knowledge of EU MDR and/or FDA medical device requirements.


• Knowledge of EU AI Act.

What We Offer:

• Opportunity to play a key role in bringing an innovative AI product to market


• Work at the intersection of clinical care, research, and AI technology


• Experience in a dynamic academic–industry startup environment


• Close collaboration with clinicians, researchers, and engineers


• Opportunity to establish and shape the company's quality foundation


• Fast\-track career progression within a rapidly growing company


• Potential opportunities to pursue a PhD


• Pension Contribution


• Healthcare contribution


• UCC Mardyke Gym contribution


• Competitive Salary


• Employee share options

Is this role for you?

In just six months since its establishment, we have secured approximately €1 million in funding, been designated an Enterprise Ireland High Potential Startup (HPSU), and been accepted to the Google Cloud Startup Program.

If you are a bright, enthusiastic, and ambitious professional who is eager to join a high\-performing, like\-minded team, we'd love to hear from you.

How to Apply:

Applicants should submit the following in PDF format:

• A cover letter outlining motivation and suitability for the role


• A CV including relevant experience

Closing Date: 30th June 2026

*Applications will be reviewed on a rolling basis. Early application is encouraged.*

Job Type: Full\-time

Pay: €60,000\.00\-€75,000\.00 per year

Benefits:

• Company pension


• Flexitime


• Gym membership


• Private medical insurance

Work Location: Hybrid remote in University College Cork, County Cork

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