Quality Assurance Specialist

1 day ago

Longford, Ireland beBeeValidation Full time €45,000 - €60,000
Job Summary

We are seeking a skilled Validation Specialist to join our team in a dynamic manufacturing environment. The successful candidate will be responsible for supporting all validation activities associated with the qualification of new tools and product introductions.


This is a hands-on role that requires strong technical knowledge, excellent communication skills, and a keen eye for detail.


Main Responsibilities:
  • Protocol Development: Develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements.
  • Solution Implementation: Design and implement solutions to sustain and improve our quality management systems (QMS).
  • Compliance Management: Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
  • Change Control: Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
  • Risk Assessment: Generate risk assessments covering cleaning, validation, and process-related risks.
  • Testing and Audits: Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols, and directly support GMP and regulatory audits.
  • Training and Development: Prepare and deliver training modules as required.
  • Data Analysis: Perform data analysis and make informed decisions/recommendations based on conclusions reached from data analysis.
  • Continuous Improvement: Support continuous improvement through Lean Six Sigma methodologies.

Requirements:
  • A third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
  • Experience in statistical analysis/Minitab/SPC/validation.
  • Excellent interpersonal, communication, influencing, and facilitation skills.
  • A minimum of two years' experience as a Validation Engineer within an injection molding or medical manufacturing environment.

Working Conditions:

This is a full-time position.


Key Skills:

The ideal candidate will possess excellent analytical, problem-solving, and communication skills, with the ability to work independently and as part of a team.

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