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Quality Validation Engineer - Medical Device, Longford
Client: Cpl
Location: Longford, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 4db567a7db98
Job Views: 2
Posted: 27.04.2025
Expiry Date: 11.06.2025
Job Description:
Experienced Validation Quality Engineer required for a medical device manufacturing facility in Longford. This role supports the qualification of new tools and product introduction on-site. It is a permanent position with benefits. Interested candidates should email an updated Word copy of their CV.
Responsibilities:
1. Write and execute process validation protocols and reports for new product introductions and revalidations, utilizing scientific and technical knowledge.
2. Develop and implement solutions to sustain and improve the Quality Management System (QMS).
3. Maintain compliance with ISO standards.
4. Participate in site change control processes, ensuring changes to validated processes are effectively managed.
5. Generate risk assessments related to cleaning, validation, and processes.
6. Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
7. Support GMP and regulatory audits.
8. Prepare and deliver training modules as needed.
9. Perform data analysis and provide recommendations based on data insights.
10. Support continuous improvement initiatives using Lean Six Sigma methodologies.
11. Develop and execute change controls.
12. Conduct root cause analysis for system failures using tools like FMEA, Fishbone diagrams, and 5 Whys.
13. Implement corrective actions through the change management system.
14. Lead and participate in cross-functional teams, including liaising with vendors.
Requirements:
1. Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
2. Experience in statistical analysis (Minitab), SPC, and validations.
3. Excellent interpersonal, communication, influencing, and facilitation skills.
4. Experience as a Validation Engineer in injection moulding or medical manufacturing environments.
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