Senior Quality Assurance Specialist

2 days ago

Longford, Ireland beBeevalidation Full time €55,000 - €70,000

Job Opportunity

In this role, you will be responsible for ensuring the accuracy and reliability of new tool and product introductions to meet organisational objectives.

Key Responsibilities:

  • Develop and execute process validation protocols and reports using scientific knowledge.
  • Create solutions to sustain and improve the quality management system (QMS).
  • Maintain compliance to ISO standards including ISO 13485 and ISO 14001.
  • Participate in site change control to ensure effective implementation of changes.
  • Conduct risk assessments for cleaning, validation, and process.
  • Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
  • Support Good Manufacturing Practice (GMP) and regulatory audits.
  • Prepare and deliver training modules as required.
  • Analyse data and make informed decisions based on conclusions from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Implement corrective action through the change management system.
  • Collaborate with cross-functional teams and liaise with vendors on projects.

Requirements:

  • A degree in Engineering, Polymer Science or equivalent manufacturing experience.
  • Experience in statistical analysis (Minitab) / Statistical Process Control (SPC) / validations.
  • Excellent interpersonal, communication, influencing, and facilitation skills.
  • A minimum of 2 years' experience as a Validation Engineer in an injection moulding or medical manufacturing environment.

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