Quality Systems Manager

Overview

An innovative Cork-based startup in the advanced life sciences space is looking for a Quality Systems Manager to build, roll out, and maintain its Quality Management System (QMS) in line with the company’s strategic timeline. The business is developing a breakthrough AI-enabled healthcare product, and this role will be central to establishing a robust quality and compliance foundation.

Quality Management System

• Set up, implement, and continuously maintain the company’s QMS in accordance with ISO 13485.
• Own quality processes such as document control, CAPA, change management, training records, supplier oversight, and non-conformance handling.
• Keep quality documents and records accurate, current, and well organised.
• Assist with both internal and external audit activities.
• Promote and lead ongoing improvement initiatives across the organisation.

Design Controls and Product Development

• Help put design control procedures into practice.
• Manage the Design History File (DHF) and related supporting documentation.
• Ensure clear traceability from requirements through risk, verification, validation, and clinical evidence.
• Partner with clinical, research, and software teams to embed quality practices throughout development work.

Risk Management and Compliance

• Support risk management work aligned with ISO 14971.
• Maintain risk files, hazard analyses, and risk assessments.
• Ensure quality and compliance expectations are built into product development activities.
• Contribute to validation and documentation for software and AI-based systems.

Regulatory Support

• Collaborate with external regulatory consultants on regulatory strategy and submissions.
• Prepare and keep up-to-date the documentation needed for regulatory reviews and filings.
• Carry out actions resulting from regulatory guidance and gap analysis.
• Track and maintain compliance documentation required for regulatory readiness.

Requirements

• A degree in Engineering, Life Sciences, Health Sciences, Quality, or a closely related field.
• At least 5 years of experience in quality assurance, quality systems, or compliance within medical devices.
• Hands-on experience implementing or maintaining QMS processes in a startup setting.
• Strong knowledge of ISO 13485.
• Practical experience with document control, CAPA, audits, and broader quality processes.
• Background supporting risk management activities.
• Excellent organisational, communication, and documentation abilities.
• Confidence working independently in a fast-moving startup environment.
• Experience in medical devices or Software as a Medical Device (SaMD).
• Working knowledge of ISO 14971 and IEC 62304.
• Exposure to regulatory submissions or regulatory readiness work.
• Experience developing or scaling a QMS in an early-stage company.
• PRRC experience.
• Familiarity with software.
• Experience supporting clinical studies or validation projects.
• Understanding of EU MDR and/or FDA medical device requirements.
• Knowledge of the EU AI Act.

Additional Information

This position is based onsite in the Cork Metropolitan Area. The role is full-time. No salary details, vacancy count, or start date were provided.