Medical Device Quality Assurance Professional

4 days ago

Athlone, County Westmeath, Ireland beBeeRegulatory Full time €60,000 - €80,000

We are seeking an experienced Quality Assurance Specialist to join our team in the medical device industry. This role is perfect for a talented professional who wants to expand their skills and work on high-profile projects.

Key Responsibilities:
  • Lead quality improvement initiatives to enhance processes and ensure regulatory compliance.
  • Support change controls, risk assessments, and process validations.
  • Analyse data and spot trends using statistical tools.
  • Write and review CAPAs, non-conformance reports, and supplier corrective actions.
  • Conduct audits and support inspections by ISO and FDA regulators.
  • Collaborate across teams to embed best practices in quality standards.
Requirements:
  • 3+ years' experience in a regulated environment - ideally medical devices or FDA/ISO 13485 certified manufacturing.
  • Degree in Quality, Science, or Engineering.
  • Strong MS Excel, Word, and PowerPoint skills.
  • Experience with FMEAs, root cause analysis, and statistical analysis.
  • Excellent attention to detail and problem-solving ability.

About this Role:

This position involves working closely with cross-functional teams to drive quality improvements and maintain regulatory compliance. The ideal candidate will have strong analytical skills, excellent communication skills, and the ability to collaborate effectively with colleagues.

What You Will Do:

  • Develop and implement quality improvement initiatives to enhance processes and reduce costs.
  • Support change controls, risk assessments, and process validations to ensure regulatory compliance.
  • Analyse data and spot trends using statistical tools to inform quality decisions.
  • Write and review CAPAs, non-conformance reports, and supplier corrective actions to ensure quality standards are met.
  • Conduct audits and support inspections by ISO and FDA regulators to ensure compliance.
  • Collaborate across teams to embed best practices in quality standards and improve overall quality performance.

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