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Quality Validation Engineer

1 month ago

Longford, Ireland Cpl Full time
Experienced Validation Quality Engineer required for medical device manufacturing facility in Longford. Will support the successful qualification of new tools / product introduction on-site. Permanent role with benefits. If interested, do email an updated word copy of your CV to [email protected]

Role
  1. Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
  2. Develop and implement solutions to sustain and improve the QMS.
  3. Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
  4. Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
  5. Generate risk assessments, covering cleaning, validation, and process.
  6. Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
  7. Directly support GMP and regulatory audits.
  8. Prepare and deliver training modules as required.
  9. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  10. Support continuous improvement through Lean Six Sigma methodologies.
  11. Execute/develop change controls.
  12. Perform root cause analysis of system failures, substandard performance, using standard tools and methods to resolve machine and system issues (e.g., FMEA, Fishbone diagrams, 5 why's, etc.).
  13. Implement subsequent corrective action through the change management system.
  14. Participate/lead cross-functional teams including liaising with vendors on projects.
Requirements
  1. Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
  2. Experience in statistical analysis (Minitab)/SPC/validations.
  3. Excellent interpersonal, communication, influencing, and facilitation skills.
  4. Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
Quality Tools
  1. Root cause investigation
  2. DEMAC Tools
  3. Six Sigma – minimum Green belt
  4. Good knowledge of plastic processing
  5. SPC
  6. Minitab
  7. 8D
  8. KPI Trending and analysis
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