Company DescriptionAre 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 doingYou'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 InformationWhat'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 | respectAt 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
