Quality Assurance Specialist

1 week ago

Galway, Galway, Ireland beBeeQuality Full time €60,000 - €85,000
Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to join our team. This individual will be responsible for maintaining high quality/performance standards on all products.

  • The successful candidate will work closely with other departments to promote the achievement of health and safety goals.
  • Deliver on all key performance indicators that contribute to the business achieving its objectives.
  • Maintain an active role in further development and continuous improvement of the Quality Management system.
  • Establish and maintain risk management principles and methods throughout the product realization process.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Provide quality guidance to the entire team in support of day-to-day deliverables.
  • Develop strong links with customer organizations and other project stakeholders.
  • Support and initiate projects to ensure continuous improvement.
  • Conduct quality reviews of validation documentation.
  • Investigate root causes and implement effective corrective actions to prevent re-occurrence of compliance issues.
  • Ensure production meets GMP standards and compliance, establish inspection standards and sampling plans as needed.
  • Prepare and update procedures and associated documentation.
  • Support customer audits and surveillance/accreditation audits.
  • Drive audits ensuring compliance with ISO 13485.
Requirements:
  • A level 8 degree in Quality or Science/Engineering field is required.
  • A minimum of 2 years of industry experience is essential.
  • A working knowledge of FDA/ISO/MDD Quality systems for Medical Device companies is necessary.
  • Experience within a similar role is an advantage.
  • Quality experience in component and device manufacturing is desirable.
  • Excellent written and oral communication skills are essential.

This is an exciting opportunity for a motivated individual to join our team and contribute to the success of our organization.

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