Senior Manufacturing Quality Engineer

2 weeks ago


Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €110,000

Quality Assurance Professional

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This is a senior quality assurance role within the medical device industry. The ideal candidate will have experience in manufacturing, supplier oversight, and regulatory compliance.

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Responsibilities

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  • Oversee quality for electronics/system-level manufacturing with contract manufacturers.">
  • Lead investigations and corrective actions for non-conformances.">
  • Support validation and documentation reviews.">
  • Monitor supplier quality and contribute to audit preparedness.">
  • Collaborate on regulatory submissions and inspection readiness.">
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Requirements

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  • Degree in Engineering, Quality, or a related discipline.">
  • 3-7 years of experience in quality assurance or manufacturing quality within a regulated industry.">
  • Strong knowledge of ISO 13485, FDA QSR, and process validation.">
  • Experience supporting regulatory audits or working with Regulatory Affairs teams.">
  • Advantageous: Contract manufacturing experience, CQE, Six Sigma, or auditing certifications.">
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About this Opportunity

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A reputable company is seeking a skilled professional to support commercial manufacturing of a connected health solution for chronic wound care.

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