Senior Quality Remediation Specialist

4 days ago

Galway, Galway, Ireland beBeeQuality Full time €120,000 - €140,000

Job Overview

We are seeking a seasoned Quality Specialist to lead remediation efforts and drive compliance improvements across our site.

About the Role

  • Lead Remediation Efforts: Collaborate with manufacturing process owners to identify and address compliance gaps.
  • Sustain Process Validation: Support IQ/OQ/PQ activities and update quality system documentation for audit readiness.
  • Closure of Compliance Issues: Drive closure of CAPAs and NCRs with effective corrective actions.
  • Technical Writing: Provide clear and concise documentation for quality and manufacturing procedures.
  • Collaboration: Work cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.

Requirements & Qualifications

  • Bachelor's degree in Engineering or a related field.
  • 25 years of experience in medical device manufacturing, quality, or remediation projects.
  • Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
  • Proven technical writing skills.
  • Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
  • Excellent problem-solving skills.

Key Skills

Process Validation Expertise: Strong understanding of IQ/OQ/PQ principles and practices.

Compliance Management: Experience in managing CAPAs and NCRs, ensuring audit readiness.

Technical Documentation: Excellent writing skills for creating clear, concise quality and manufacturing procedures.

Cross-Functional Collaboration: Proven ability to work effectively with multiple teams to achieve compliance goals.

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