Lead Quality Systems Specialist

3 days ago

Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000
Job Summary

This position involves the implementation and enhancement of quality management systems. A successful candidate will collaborate with experienced professionals in a dynamic environment, contributing to impactful projects.

The ideal candidate will possess experience in the medical device or pharmaceutical industry, familiarity with relevant regulations, and excellent communication and organisational skills.

Key Responsibilities
  • Maintain corrective action and complaint systems.
  • Manage data collection and analysis for quality systems.
  • Prepare and present monthly quality reports.
  • Conduct gap assessments on quality management system regulations.
  • Support software validation activities.
  • Support the management review process.
  • Contribute to the maintenance and continuous improvement of quality management processes.
  • Support other quality system activities.
Requirements
  • Degree-educated in engineering, science, or quality assurance discipline.
  • A minimum of five years' relevant experience in the medical device or pharmaceutical industry.
  • Familiarity with ISO 13485, ISO 14971, Medical Device Regulation 2017/745, and FDA QMSRs.
  • Good communication and organisational skills.
Benefits
  • Competitive salary and bonus.
  • Pension scheme with generous employer contributions.
  • Private medical insurance.
  • Paid sick leave and group life cover.
  • Flexible working arrangements.
Company Values
  • Collaborative.
  • Innovative.
  • Empowering.
  • Patient-centric.
  • Acting with integrity.

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