We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• Key Quality representative in multidisciplinary team to support new production line and process validation projects, ensuring compliance.
• Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
• Ensure correct validation processes application (IQ/OQ/PQ/PPQ) via proactive support, and review and approval of documentation. Investigate and trouble-shoot problems which occur and determine solutions.
• Ensure that the change control procedures are correctly applied, review and approve project and Quality documentation. Identify critical areas for improvement and prioritize and execute the quality improvements initiatives resulting from this.
• As needed, perform or support non-conformance / CAPA root cause investigations, defining action plans and drives these to completion.
• Identity and implement improvements to validation activities, processes and procedures (e.g. efficiency and compliance improvements).
• Responsible for inspection readiness of the projects in scope of their work, and act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA);
• Escalate any quality or compliance issues to upper management.
Education & Experience
• At least 5 years of relevant work experience preferably in high volume, highly automated medical device industry.
• A relevant Bachelor or Master of Science degree (technical, life science or related).
• Working knowledge of validation of products/equipment/ processes, computer system validation, statistics, risk management, change control.
• Knowledge of relevant Medical Device regulations (GMP, MDR, QSR CFR 820, ISO 13485, ISO 14971).
• Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation & full knowledge of industry practices.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480