Quality Systems Specialist

Company Description Are you ready to take your career in manufacturing to the next level? Look no further! LGC, a world-class Clinical Diagnostics company in the heart of Tipperary, is seeking a Quality Systems Specialist to join our ambitious team. We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results. In this role, you will play a crucial role in ensuring flawless quality across our manufacturing processes. This is an exceptional opportunity to be part of a proven organisation and make a significant impact in the field of manufacturing. Job DescriptionWhat you’ll be doing You’ll lead and support a broad range of quality systems activities, including:

• Implementing, maintaining, and improving our Quality Management System (QMS)
• Maintaining relationships with Economic Operators (Suppliers, Distributors, Importers, and Authorised Representatives)
• Reviewing and approving new Economic Operators in collaboration with Purchasing and Business Development teams
• Developing quality agreements with Economic Operators alongside Purchasing and Legal
• Monitoring supplier performance and supporting investigations of non-conforming materials (e.g., SCARs)
• Leading internal and supplier audits as the site Lead Auditor
• Supporting Incoming Quality Assurance – raw material specifications, CoA reviews, and visual inspections
• Participating in external audits (HPRA, Notified Body, Customer)
• Contributing to NCs, CAPAs, Change Controls, and Document Control
• Reviewing and approving SOPs, manufacturing documentation, and material control records
• Maintaining strong housekeeping and compliance with Health & Safety policies

Qualifications

• B.Sc. in Science, Engineering, QA, or a related field
• Lead Auditor qualification
• Minimum 2 years’ experience in a quality role, ideally within diagnostics or regulated manufacturing
• Solid understanding of regulatory standards: FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, IVDR (EU) 2017/746
• Familiarity with ISO 14971 (Risk Management)

Additional Information What’s in it for you?

• 25 days annual leave
• Health allowance and life assurance
• Retail discounts (local and national)
• 24/7 Employee Assistance Programme
• Recognition & reward schemes
• Ongoing career development & progression opportunities
• A supportive culture driven by our values:

Passion | curiosity | integrity | brilliance | respect At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know. #lgcij