We are seeking an experienced Quality Systems Specialist to join a growing MedTech company in Athlone, ath. The Quality Systems Specialist will be responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable. and international regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 27001, and other applicable regulatory requirements. This position supports both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices. This is a permanent opportunity offering hybrid working.
Responsibilities:
1. Maintain the Quality Management System (QMS) and activities to ensure that all operations are fully in compliance with FDA, ISO, and other regulatory requirements.
2. Maintain quality system procedures, work instructions, and records.
3. Ensure timely and accurate document control and change management activities.
4. Track and report metrics and key performance indicators for the Quality Management System.
5. Monitor and trend quality system metrics (CAPAs, complaints, audit findings, and prepare reports for management reviews.
6. Support Corrective and Preventive Actions (CAPA) by conducting root cause investigations, effectiveness checks, and documentation.
7. Assist with risk management processes.
8. Continuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments, reporting via site metrics, KPI's and Quality Management Review.
9. Management of the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.
10. Support / host Client quality audits. Inclusive of addressing findings and required actions.
11. Document Control - Site lead for managing SOPs and Document Control.
12. Site lead for training compliance to SOPs.
13. Other duties as required to support the growing Quality organisation.
14. Building authentic relationships, ensuring cross-functional Quality Systems meetings are held so that Quality Systems can collaborate with all stakeholders of the QMS to drive improvements.
Essential Criteria:
15. Flexibility to travel to the US is required to support business activities and Quality Audits.
16. Bachelor's degree in a Science-related discipline.
17. Minimum of 3–5 years' professional experience in the Medical Device industry within a Quality Assurance role.
18. Experience with Medical Device software is an advantage.
19. Strong knowledge of current QMS requirements with extensive experience in ISO 13485; knowledge of ISO 27001 is an advantage.
20. Proven ability to clearly and concisely communicate with both internal and external stakeholders.
21. Strong organizational and presentation skills, with the ability to communicate Quality Metrics to management.