Quality Systems Specialist — Diagnostics & Regulatory Assurance

LGC Limited; Ballina; On-site; EUR 52,000 - 72,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Discounts with retailers

24/7 Employee Assistance Programme

Job summary

LGC Clinical Diagnostics, Ballina, is seeking a Quality Systems Specialist to join the QA team. This role supports the maintenance and improvement of the site’s quality systems, including supplier qualification, supplier audits, CAPA, and document control. It offers an opportunity for career growth within a global life sciences company.

The successful candidate will have a B.Sc. in a science/engineering/QA discipline, at least 2 years in quality, and strong knowledge of FDA 21 CFR 820, ISO

Qualifications

• B.Sc. in Science/Engineering/QA or related discipline.
• Minimum 2 years practical quality experience.
• Knowledge of FDA 21 CFR820, ISO13485, IVDD/IVDR and international regulatory requirements.
• Familiar with ISO 14971.

Responsibilities

• Implement, maintain and improve quality system at Technopath Manufacturing Business.
• Manage control of Economic Operators (Suppliers/Distributors/Importers/Authorized Reps).
• Review and approve new Economic Operators per quality system requirements.
• Develop quality agreements with Economic Operators with Purchasing/Legal.
• Lead internal audits and supplier quality audits as site Lead Auditor.
• Support CAPA, Change Controls and Documentation Control activities.
• Update SOPs and manufacturing documentation; ensure compliance with SOPs.

Skills

QA knowledge

Regulatory compliance

Documentation control

Auditing

Education

B.Sc. in Science/Engineering/QA

Tools

ISO 13485

FDA 21 CFR 820

IVDR (EU) 2017/746

Job description

LGC Clinical Diagnostics, Ballina, is seeking a Quality Systems Specialist to join the QA team. This role supports the maintenance and improvement of the site’s quality systems, including supplier qualification, supplier audits, CAPA, and document control. It offers an opportunity for career growth within a global life sciences company.

The successful candidate will have a B.Sc. in a science/engineering/QA discipline, at least 2 years in quality, and strong knowledge of FDA 21 CFR 820, ISO