Remediation Compliance Expert

3 days ago

Galway, Galway, Ireland beBeeProcess Full time €60,000 - €85,000

Manufacturing Engineer Role Overview

Job Summary:

We are seeking an experienced Manufacturing Engineer to drive compliance improvements and process validation initiatives. This role involves partnering with manufacturing teams to identify and remediate compliance gaps.

  • Partner with manufacturing teams to identify and remediate compliance gaps.
  • Support manufacturing process validation activities (IQ/OQ/PQ).
  • Update quality system documentation and technical files to ensure audit readiness.
  • Drive closure of CAPAs and NCRs with effective corrective actions.
  • Provide clear and concise technical writing for quality and manufacturing procedures.
Key Responsibilities:

This position requires strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management. The ideal candidate should have a Bachelor's degree in Engineering or Quality-related discipline and 2–5 years of experience in medical device manufacturing, quality, or remediation projects.

  • Bachelor's degree in Engineering or Quality-related discipline.
  • 2–5 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 and documentation skills.
  • Familiarity with industry quality standards.

Benefits of this Opportunity:

  • Collaborative work environment.
  • Opportunity to contribute to the success of our client.

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