Senior Manufacturing Quality Assurance

2 weeks ago


Galway, Galway, Ireland beBeeManufacturing Full time €65,000 - €85,000

Job Summary:

We are seeking a seasoned Senior Manufacturing Quality Assurance professional to join our team in Galway. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of product quality and compliance with regulatory requirements.

About the Role:

This is an exciting opportunity to work with a leading medical device company that is dedicated to developing innovative solutions for chronic wound care. As a Senior Manufacturing QA Engineer, you will play a critical role in supporting commercial manufacturing operations, ensuring product quality, and maintaining compliance with ISO 13485 and FDA QSR regulations.

Your Key Responsibilities:

  • Oversee quality for electronics/system-level manufacturing with contract manufacturers
  • Lead investigations and CAPA for non-conformances
  • Support IQ/OQ/PQ validations and documentation reviews
  • Monitor supplier quality and contribute to audit preparedness
  • Collaborate on regulatory submissions and inspection readiness

Requirements:

  • Degree in Engineering, Quality, or a related discipline
  • 3-7 years in QA 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

What We Offer:

In this role, you will have the opportunity to work with a dynamic team, develop your skills, and contribute to the success of our organization. If you are a motivated and experienced quality professional looking for a new challenge, we encourage you to apply.



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