Role Summary:
Quality Technician I supports the organisation’s commitment to delivering safe and effective products by ensuring compliance with ISO 13485 and related regulatory standards. This role focuses on critical quality activities, including particulate counting, equipment calibration, supplier qualification and monitoring, and maintaining the Quality Management System (QMS). Through accurate data collection, environmental monitoring, and proactive supplier management, the Quality Technician I ensures the integrity of processes and materials, contributing to continuous improvement and delivering high-quality products to customers.

Education:

• Bachelor’s (required

Experience:

• related field: 2 years (required

· · Perform routine particulate counting and environmental monitoring in controlled environments
· Conduct calibration, maintenance, and equipment verification, ensuring all instruments function correctly and within specifications.
· Support implementing and maintaining the Quality Management System (QMS) to meet ISO 13485 requirements.
· Assist with supplier management activities, including supplier qualification, monitoring, and periodic revaluation to ensure continued compliance with regulatory and company standards.
· Review and maintain supplier documentation, such as certificates of analysis, quality agreements, and audit reports.
· Collaborate with suppliers to address quality issues, ensuring timely implementation of corrective and preventive actions (CAPA).
· Assist with preparing, executing, and documentation of internal and external audits.
· Document, investigate, and support the resolution of non-conformances, deviations, and complaints.
· Conduct sampling and testing raw materials, in-process materials, and finished products according to defined procedures.
· Maintain accurate and complete records of quality-related data, test results, calibration activities, and supplier performance metrics.
· Assist in creating, reviewing, and revising quality documentation, including procedures, forms, and work instructions.
· Monitor and maintain cleanliness and compliance in controlled environments, adhering to established protocols.
· Participate in root cause analysis and support the implementation of CAPA.
· Ensure compliance with established SOPs, regulatory requirements, and safety standards.
· Collaborate with cross-functional teams to address quality concerns and provide support during product inspections or testing.
Provide input into identifying process improvements to enhance product quality and operational efficiency.
Job Type: Full-time

Benefits:

• Additional leave
• Bike to work scheme
• Company events
• Company pension
• Employee assistance program
• On-site parking
• Private medical insurance
• Sick pay
• Wellness program

Schedule:

• 8 hour shift
• Day shift
• Holidays
• Monday to Friday
• No weekends
• Overtime

Education:

• Bachelor’s (required)

Experience:

• related field: 2 years (required)

Language:

• English (required)

Location:

• Mervue Business Park, CO. Galway (required)

Work Location: In perso