Quality Systems Technician Full Time Job Description Smart Reactors are currently seeking a Quality Systems Technician to join our team located in Parkmore, Galway, Ireland. About Smart Reactors Smart Reactors is headquartered in Galway, Ireland and is a trusted provider of medical device coating technologies. We provide solutions to reduce thromboembolic complications, while promoting Cell Proliferation & Healing in the case of implant devices. The company offers a wide range of services from early coating selection to manufacturing process transfer, while supporting regulatory approval & commercialisation. Job Summary The Quality Systems Technician will support our R&D Department, playing a vital role in managing & implementing ISO 13485 quality systems. This position will collaborate closely with internal teams ensuring compliance and promoting a culture of quality across the organization. Key Responsibilities QMS Management -Responsible for the coordination, upgrade & maintenance to the ISO13485 QMS system Quality Documentation: Manage quality documentation, including procedures, protocols, and reports and records, to ensure compliance with customer specifications and industry standards in a timely manner. Customer Interface: Maintain ongoing communication with customers to ensure all quality requirements are met, fostering strong relationships and understanding of customer needs. 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 Request (CAPA, SCAR). Qualifications Third Level qualification in Quality/ Science A working knowledge of quality systems(ISO 13485) is essential Preferable Auditing experience to the requirements of ISO 13485/ 21 CRF Part 820 Experience 2+ years industry experience working in a regulated medical device/ manufacturing area. Good knowledge of FDA 21CFR820 and international regulatory requirements Familiarity with relevant regulatory and quality standards (e.g., GMP, ISO). Excellent problem-solving abilities and critical thinking skills. Strong written and verbal communication skills. Ability to work independently and as part of a team in a fast-paced environment. Strong interpersonal skills and the ability to communicate well both verbally and in writing. Location and Travel On-site, Parkmore Galway Flexible work hours may be needed to meet project deadlines or accommodate time-sensitive experiments. Equal Opportunity: All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.