About Smart Reactors
Smart Reactors is a trusted provider of medical device coating technologies, headquartered in Galway, Ireland. We offer solutions to reduce thromboembolic complications and promote Cell Proliferation & Healing for implant devices.
We provide a wide range of services from early coating selection to manufacturing process transfer, while supporting regulatory approval and commercialization.
Job Summary
The Quality Systems Technician will support our R&D Department by managing and implementing ISO 13485 quality systems. This role involves collaborating closely with internal teams to ensure compliance and promoting a culture of quality across the organization.
Key Responsibilities:
QMS Management
Coordinate, upgrade, and maintain the ISO13485 QMS system to ensure it remains effective and compliant.
Quality Documentation
Manage quality documentation, including procedures, protocols, and reports and records, to meet customer specifications and industry standards in a timely manner.
Cross-Department Collaboration
Interface daily with other departments to promote quality awareness and integrate quality initiatives throughout the organisation.
Internal Audits/CAPA
Coordinate audits and Corrective Action Requests (CAPA, SCAR) to ensure continuous improvement and compliance.
Qualifications:
* Third Level qualification in Quality/Science
* A working knowledge of quality systems (ISO 13485)
* Preferable auditing experience to the requirements of ISO 13485/21 CFR Part 820
* 2+ years' industry experience working in a regulated medical device/manufacturing area
* Familiarity with relevant regulatory and quality standards (e.g., GMP, ISO)
Location and Travel
This role is based on-site in Parkmore, Galway, and may require flexible work hours to meet project deadlines or accommodate time-sensitive experiments.