Manufacturing Quality Assurance Specialist

1 week ago


Longford, Ireland Real Full time
Job Description

At Real, we are seeking a highly skilled Validation Engineer to join our team. As a key member of our medical equipment manufacturing department, you will be responsible for ensuring the quality and integrity of our products.

Responsibilities:
  1. We are looking for an experienced professional to develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
  2. You will be responsible for developing and implementing solutions to sustain and improve our Quality Management System (QMS).
  3. Maintain and support compliance to ISO 13485 and ISO 14001 systems standards, ensuring that all changes to validated processes are effectively identified and implemented.
  4. Participate in site change control, generating risk assessments covering cleaning, validation, and process, and review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
  5. Directly support Good Manufacturing Practice (GMP) and regulatory audits, preparing and delivering training modules as required.
  6. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis, supporting continuous improvement through Lean Six Sigma methodologies.
  7. Execute/develop change controls and 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.
  8. Implement subsequent corrective action through the change management system, participating/leading cross-functional teams including liaising with vendors on projects.


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