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Quality Systems Engineer

  • Division: Engineering
  • Contact Email: emma.cawley@collinsmcnicholas.ie
  • Job Ref: 24141

Are you an experienced Quality Systems Engineer looking for an opportunity to lead a critical compliance project within the medical device sector? We are partnering with a leading organisation in Galway that is dedicated to delivering high-quality, FDA-compliant medical technologies. This role offers a unique chance to drive quality system enhancements, ensuring compliance with US FDA QMSR regulations.

Initially, you will spearhead a key project focused on aligning the company’s Quality Management System (QMS) with US FDA QMSR requirements. Once this project is completed (expected within 18-24 months), you will transition into a long-term quality systems management role, overseeing internal audits, document control, and regulatory compliance.

Key Responsibilities:

  • Lead the development and compliance of the Quality Management System (QMS) with FDA QMSR regulations.
  • Conduct a gap analysis, propose system changes, and oversee their implementation.
  • Create and update quality procedures, ensuring compliance with industry standards.
  • Provide progress reports to senior management, tracking project milestones.
  • Support and participate in third-party audits and regulatory inspections.
  • Drive continuous improvement initiatives, applying problem-solving tools like CAPA and root cause analysis.
  • Oversee internal audits and maintain compliance with ISO 13485 and GMP regulations.
  • Act as a key point of contact for quality systems maintenance, including document control and performance monitoring, after project completion.

Key Requirements:

  • 4+ years of experience in the medical device industry, specifically in a US FDA-compliant environment.
  • Degree in Engineering, Science, Quality Management, or a related field.
  • Strong expertise in ISO 13485 and US FDA QMSR compliance.
  • Experience in quality systems development, procedure writing, and regulatory compliance.
  • Certification in Quality Management (e.g., ISO 13485 Lead Auditor) is preferred.

Why Join?

  • Competitive benefits including healthcare, pension, life assurance, paid maternity & paternity leave.
  • Career growth opportunities with access to learning and development funding.
  • Employee wellbeing initiatives, sports & social clubs, and corporate discounts.
  • Convenient Galway location, well connected to public transport with free parking & bike-to-work scheme.

For more details on this role, feel free to reach out to Emma Cawley at emma.cawley@collinsmcnicholas.ie.

Kindly note that, given the expected high volume of applications, we can only respond to candidates whose qualifications closely match the specific requirements of the role. We genuinely value your interest in this opportunity and thank you for your understanding.