Job Description:
You will lead and support a broad range of quality systems activities, including implementing, maintaining, and improving our Quality Management System (QMS). As a key member of the team, you will collaborate with cross-functional teams to ensure compliance with regulatory standards.
About the Role:
* 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
* Leading internal and supplier audits as the site Lead Auditor
* Supporting Incoming Quality Assurance - raw material specifications, Co A reviews, and visual inspections
* Participating in external audits (HPRA, Notified Body, Customer)
* Contributing to NCs, CAPAs, Change Controls, and Document Control
Required Skills and Qualifications:
* Bachelor's or Master's degree 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)
Benefits:
* 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
We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities.
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