Quality Technician 3 (Front End Night Shift)
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- Athenry, Co Galway
- Permanent
- Full-time
- You will support Quality Engineering activities, including Change Order processing, Nonconformance Events (NCEs), Nonconforming Material Reports (NCMRs), and CAPA investigations.
- You will collect manufacturing and inspection data and perform inspections to support investigations led by Quality Engineers.
- You will support production through regular presence on the manufacturing floor and assist the inspection team with questions related to inspection methods, processes, and specifications.
- You will support Quality Engineering in ensuring compliance with internal procedures and external standards and regulations, including GMP, GLP, ISO, and Six Sigma requirements.
- You will update and maintain quality assurance procedures, protocols, and methods for processing materials into partially finished and finished products.
- You must ensure manufacturing and production processes comply with internal quality systems and applicable safety, quality, and regulatory requirements to enable worldwide product distribution.
- You will support the investigation, assessment, verification, and disposition of nonconforming materials in collaboration with cross‑functional teams.
- You will perform routine line audits to verify that systems are compliant, effective, and operating as intended.
- You will provide day‑to‑day quality support to Quality Engineering and Operations by addressing production quality issues and supporting the implementation of corrective and corrective actions.
- You must identify opportunities for quality and process improvement and contribute to continuous improvement initiatives that enhance product quality and process efficiency.
- You must communicate any concerns related to work processes, environmental impact, health, or safety to your manager in a timely manner.
- You must read and interpret specifications, inspection criteria, and engineering drawings, applying requirements using appropriate and properly configured inspection tools.
- You will demonstrate sound decision‑making skills and the ability to work independently with minimal supervision.
- You may assist in the training and mentoring of junior technicians, as required.
- You must apply intermediate computer skills, including effective use of Microsoft Office applications.
- You must demonstrate excellent attention to detail and strong documentation practices. You will perform additional duties as assigned in support of Quality and Operations objectives.
- You will demonstrate 4–6 years of experience working effectively in a medical device or similarly regulated manufacturing environment, applying quality systems with confidence and consistency.
- You will show strong shop‑floor presence and ownership of assigned quality systems, proactively engaging with Operations to support compliance and real‑time issue resolution.
- You will actively contribute to nonconformance investigations and CAPA activities through timely assessment, effective collaboration, and thorough documentation.
- You will maintain audit‑ready behaviours at all times, with a clear understanding of FDA, ISO, and MDSAP requirements and the ability to support inspections and audits confidently.
- You will demonstrate sound judgement and confident decision‑making, taking ownership of issues while knowing when and how to escalate appropriately.
- You will work effectively both independently with minimal supervision and collaboratively within cross‑functional teams to achieve quality and operational objectives.
- Level 6 in Quality or a related discipline.
- Minimum of 4 years of experience in a regulated industry.
- Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820,
- Experience working on cross site or global system projects. Audit experience with FDA, BSI, or MDSAP. Experience with manufacturing systems, MES, ERP, or QMS applications.