Senior Quality Systems Professional

1 week ago

Kilkenny, Kilkenny, Ireland beBeeQuality Full time €55,000 - €75,000

Job Description:

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  • Maintain and improve the Quality Management System (QMS) to ensure compliance with applicable U.S. and international regulations and standards.">
  • Support both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices.">
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Key Responsibilities:

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  2. Maintain the Quality Management System (QMS) and activities to ensure that all operations are fully in compliance with FDA, ISO, and other regulatory requirements.">
  3. Maintain quality system procedures, work instructions, and records.">
  4. Ensure timely and accurate document control and change management activities.">
  5. Track and report metrics and key performance indicators for the Quality Management System.">
  6. Monitor and trend quality system metrics (CAPAs, complaints, audit findings, etc.) and prepare reports for management reviews.">
  7. Support Corrective and Preventive Actions (CAPA) by conducting root cause investigations, effectiveness checks, and documentation.">
  8. Assist with risk management processes.">
  9. Continuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments, reporting via site metrics, KPIs, and Quality Management Review.">
  10. Management of the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.">
  11. Support/host Client quality audits. Inclusive of addressing findings and required actions.">
  12. Document Control - Site lead for managing SOPs and Document Control.">
  13. Site lead for training compliance to SOPs.">
  14. Other duties as required to support the growing Quality organisation.">
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Requirements:

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  • Flexibility to travel to the US is required to support business activities and Quality Audits.">
  • Bachelor's degree in a Science-related discipline.">
  • Minimum of 3-5 years' professional experience in the Medical Device industry within a Quality Assurance role.">
  • Experience with Medical Device software is an advantage.">
  • Strong knowledge of current QMS requirements with extensive experience in ISO 13485; knowledge of ISO 27001 is an advantage.">
  • Proven ability to clearly and concisely communicate with both internal and external stakeholders.">
  • Strong organizational and presentation skills, with the ability to communicate Quality Metrics to management.">
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About This Opportunity:

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This is a permanent opportunity offering hybrid working.

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