Manufacturing Quality Assurance Specialist

About the role

LGC Clinical Diagnostics is seeking a Manufacturing Quality Assurance Specialist to join its team in Tipperary, Ireland. You will support the release of raw materials, components and finished devices while ensuring compliance with regulatory and internal quality standards.

Key responsibilities

• Review batch records and release raw materials, components and finished devices.
• Approve protocols, reports and documentation updates in line with Technopath Clinical Diagnostics (TCD) procedures and regulatory requirements.
• Apply statistical QA methods and quality tools to monitor and analyse production performance.
• Identify improvement opportunities and ensure all process developments follow the Quality Management System.
• Implement and maintain QMS requirements for ISO 13485, MDSAP, IVDD, IVDR and FDA.
• Conduct internal audits and provide training on QMS processes.
• Handle, store and document controlled drugs in accordance with internal and regulatory rules.
• Maintain housekeeping and comply with health and safety requirements.

Required profile

• B.Sc. in Science, Engineering, QA or related field, or equivalent experience.
• Minimum 3 years of practical experience in a quality function.
• Strong knowledge of FDA 21CFR820, ISO 13485:2016, IVDD 98/79/EC and IVDR EU 2017/746.
• Excellent communication, attention to detail and ability to work independently or in a team.

Required skills

• FDA 21CFR820
• ISO 13485:2016
• IVDD 98/79/EC
• IVDR EU 2017/746
• Statistical QA methods
• Quality tools (e.g., root‑cause analysis, CAPA)
• Internal auditing