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Regulatory Compliance Manager
2 weeks ago
We require a highly motivated and experienced Validation Quality Engineer to join our team in Longford. As a key member of our team, you will play a crucial role in supporting the successful qualification of new tools and product introduction on-site at a medical device manufacturing facility.
About the Team:- You will work closely with the production team to ensure that all products meet quality and regulatory standards.
- You will develop and implement process validation protocols and reports for new product introductions and revalidations.
- You will sustain and improve the QMS through the development and implementation of solutions.
- You will maintain compliance to ISO 13485 and ISO 14001 systems standards by participating in site change control and ensuring effective identification and implementation of changes to validated processes.
- You will generate risk assessments covering cleaning, validation, and process risks.
- You will review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
- You will support GMP and regulatory audits.
- You will prepare and deliver training modules as required.
- You will perform data analysis and make informed decisions/recommendations based on conclusions reached from data analysis.
- You will support continuous improvement through Lean Six Sigma methodologies.
- You will execute/develop change controls and perform root cause analysis of system failures, substandard performance using standard tools and methods.
- You will implement subsequent corrective action through the change management system.
- You will participate/lead cross-functional teams including liaising with vendors on projects.
